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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00546416




Registration number
NCT00546416
Ethics application status
Date submitted
11/09/2000
Date registered
27/01/2003
Date last updated
25/03/2015

Titles & IDs
Public title
S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma
Scientific title
Phase III Trial of High Dose Interferon Alfa 2-b Versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients With High Risk Melanoma
Secondary ID [1] 0 0
U10CA032102
Secondary ID [2] 0 0
S0008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma (Skin) 0 0
Unspecified Adult Solid Tumor, Protocol Specific 0 0
Unspecified Childhood Solid Tumor, Protocol Specific 0 0
Paget's Disease of Bone 0 0
Leukemia 0 0
Cutaneous T Cell Lymphoma 0 0
Peripheral T Cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Breast
Neurological 0 0 0 0
Other neurological disorders
Injuries and Accidents 0 0 0 0
Poisoning
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - interleukin-2
Treatment: Other - filgrastim
Treatment: Other - interferon alfa
Treatment: Drugs - cisplatin
Treatment: Drugs - dacarbazine
Treatment: Drugs - vinblastine
Treatment: Drugs - Zoledronic Acid
Treatment: Drugs - Risedronate
Treatment: Drugs - Placebo to Risedronate
Treatment: Drugs - Placebo to Zoledronic Acid
Treatment: Other - Calcium and Vitamin D

Experimental: AC followed by Docetaxel + Herceptin (AC?TH) - Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.

Active comparator: Arm I - Patients receive interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity.

Experimental: Arm II - Patients receive cisplatin IV over 30 minutes followed by vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 1 hour on day 1, interleukin-2 IV over 96 hours on days 1-4, and interferon alfa SC on days 1-5, 8, 10, and 12. In addition, patients receive filgrastim (G-CSF) SC on days 6-15. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Experimental: Docetaxel + Carboplatin + Herceptin (TCH) - Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.

Experimental: Zoledronic Acid and Placebo to Risedronate - Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.

Active comparator: Risedronate and Placebo to Zoledronic Acid - Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.

Experimental: Peripheral T-cell Lymphoma (PTCL) - Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.

Experimental: Cutaneous T-cell Lymphoma (CTCL) - Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.


Treatment: Other: interleukin-2
Given IV

Treatment: Other: filgrastim
Given subcutaneously

Treatment: Other: interferon alfa
Given IV and subcutaneously

Treatment: Drugs: cisplatin
Given IV

Treatment: Drugs: dacarbazine
Given IV

Treatment: Drugs: vinblastine
Given IV

Treatment: Drugs: Zoledronic Acid
Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion.

Treatment: Drugs: Risedronate
Oral risedronate 30 mg capsules.

Treatment: Drugs: Placebo to Risedronate
Oral placebo of risedronate capsules.

Treatment: Drugs: Placebo to Zoledronic Acid
5 mL of sterile water one dose intravenous infusion.

Treatment: Other: Calcium and Vitamin D
Calcium and vitamin D supplements were supplied.

Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
5-year Overall Survival
Assessment method [1] 0 0
Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.
Timepoint [1] 0 0
Every three months for a year, every six months for years 2-5, annual for years 5-10
Primary outcome [2] 0 0
5-year Relapse-Free Survival
Assessment method [2] 0 0
Measured from date of registration to date of first observation of progressive disease or death due to any cause.
Timepoint [2] 0 0
Every three months for the first year, every 6 months for years 2-5, annually for years 6-10
Primary outcome [3] 0 0
Percentage of Participants With Disease Free Survival at 5 Years
Assessment method [3] 0 0
Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.
Timepoint [3] 0 0
From randomization until relapse or death or up to 5 years
Primary outcome [4] 0 0
Number of Patients Who Achieve Therapeutic Response at 6 Months.
Assessment method [4] 0 0
Therapeutic response is defined as a reduction of at least 75% from baseline (Visit 1) in total serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase at the end of six months.
Timepoint [4] 0 0
6 months
Primary outcome [5] 0 0
Number of Participants With a Response
Assessment method [5] 0 0
A rigorous composite assessment was employed with uni-dimensional measurements of skin and visceral disease sites assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (= 30% per RECIST) or lymph nodes (= 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.
Timepoint [5] 0 0
up to 56.5 days
Primary outcome [6] 0 0
Duration of Response (DOR)
Assessment method [6] 0 0
DOR is defined as the date response was noted until disease was no longer considered to be responding. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and the International Working Group Criteria (IWG).Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (= 30% per RECIST) or lymph nodes (= 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.
Timepoint [6] 0 0
up to 127 months
Secondary outcome [1] 0 0
Toxicity
Assessment method [1] 0 0
Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event
Timepoint [1] 0 0
While on treatment, patients on the HDIFN arm were assessed weekly for the 1st month, then every 2 weeks for the 2nd month, then every 3 months therafter; patients on the biochemo arm were assessed daily for the 1st 5 days, then weekly thereafter.
Secondary outcome [2] 0 0
Percentage of Participants With Disease Free Survival at 10 Years
Assessment method [2] 0 0
Disease free survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.
Timepoint [2] 0 0
From randomization until relapse or death or up to 10 years
Secondary outcome [3] 0 0
Overall Survival- Percentage of Participants Who Survived at 10 Years
Assessment method [3] 0 0
Overall survival of the participants was measured from the date of randomization up to the date of death due to any cause. Overall survival was estimated using the Kaplan-Meier method.
Timepoint [3] 0 0
From randomization until death or up to 10 years
Secondary outcome [4] 0 0
Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28
Assessment method [4] 0 0
The percent change in serum alkaline phosphatase from baseline to day 28 was measured.
Timepoint [4] 0 0
Baseline and day 28
Secondary outcome [5] 0 0
Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10
Assessment method [5] 0 0
The percent change in serum C-telopeptide from baseline to day 10 was measured.
Timepoint [5] 0 0
Baseline and day 10
Secondary outcome [6] 0 0
Relative Change in Urine Alpha C-telopeptide (a-CTx) in ug/mmol at Day 10
Assessment method [6] 0 0
The percent change in urine alpha C-telopeptide from baseline to day 10 was measured.
Timepoint [6] 0 0
Baseline and day 10
Secondary outcome [7] 0 0
Time to First Therapeutic Response
Assessment method [7] 0 0
A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase.
Timepoint [7] 0 0
182 days
Secondary outcome [8] 0 0
Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline
Assessment method [8] 0 0
Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range.
Timepoint [8] 0 0
Baseline and day 28
Secondary outcome [9] 0 0
Change in Pain Severity Score
Assessment method [9] 0 0
Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.
Timepoint [9] 0 0
Baseline and day 182
Secondary outcome [10] 0 0
Change in Pain Interference Score
Assessment method [10] 0 0
Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.
Timepoint [10] 0 0
Baseline and day 182
Secondary outcome [11] 0 0
Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period
Assessment method [11] 0 0
Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase.
Timepoint [11] 0 0
8 years was the maximum
Secondary outcome [12] 0 0
Number of Participants With a Partial Disease Relapse During the Extended Observation Period
Assessment method [12] 0 0
Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase \>= 50% from the serum alkaline phosphatase measurement at month 6 and at least 1.25 times the upper normal limit.
Timepoint [12] 0 0
8 years was the maximum
Secondary outcome [13] 0 0
Number of Participants With a Disease Relapse During the Extended Observation Period
Assessment method [13] 0 0
Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was \>= 80% of baseline serum alkaline phosphatase value.
Timepoint [13] 0 0
8 years was the maximum
Secondary outcome [14] 0 0
Number of Participants With Adverse Events
Assessment method [14] 0 0
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Timepoint [14] 0 0
147 months and 5 days
Secondary outcome [15] 0 0
Median Number of Cycles of Depsipeptide Administered
Assessment method [15] 0 0
Participants were administered Depsipeptide and cycles (each cycle is 21 days) were monitored from the prescribed dose or higher to determine reductions (if needed) to maintain tolerability.
Timepoint [15] 0 0
83 cycles (i.e., each cycle is 21 days)
Secondary outcome [16] 0 0
Time to Progression
Assessment method [16] 0 0
Time to progression is defined from the first day of therapy until documentation of progressive disease. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the International Working Group (IWG) criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.
Timepoint [16] 0 0
Until disease progression, or 30 days following off study date
Secondary outcome [17] 0 0
Fold Change in Histone Acetylation
Assessment method [17] 0 0
Fold change is calculated by dividing the level of histone acetylation in a treated sample (at 4, 24, and 48 hours) measured as intensity on a dot blot immunoassay, divided by the intensity in the pre-treatment sample. We considered a = 2-fold change a measurable difference, and indicative of successful HDAC inhibition by romidepsin (depsipeptide).
Timepoint [17] 0 0
4 hours, 24 hours, and 48 hours after Romidepsin
Secondary outcome [18] 0 0
Multidrug Resistance Protein 1 (MDR1) or ATP-binding Cassette Sub-family B Member 1 (ABCB1) Gene Expression
Assessment method [18] 0 0
Total ribonucleic acid (RNA) was isolated from peripheral blood mononuclear cells or patient tissue biopsies and analyzed by quantitative polymerase chain reaction (qPCR). Expression of MDR-1/ABCB1 was determined by qPCR relative to an RNA standard, then normalized to ribosomal RNA (rRNA). Fold change is calculated by dividing the level of MDR-1 in a treated sample (at 4, 24, and 48 hours) measured by qPCR, divided by MDR-1 in the pre-treatment sample. We considered a = 2-fold change a measurable difference, and indicative of successful HDAC inhibition by romidepsin (depsipeptide).
Timepoint [18] 0 0
4 hours, 24 hours, and 48 hours after Romidepsin

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically proven melanoma of cutaneous origin or from unknown primary at initial presentation of primary or first clinically detected nodal or satellite/in-transit recurrence

* No distant metastases
* No melanoma of ocular, mucosal, or other non-cutaneous origin
* One of the following criteria must apply for patients with newly diagnosed melanoma OR a previously diagnosed primary with current subsequent, clinical, regional nodal disease and/or satellite/in-transit disease:

* Ulcerated primary melanoma with 1 or more involved lymph nodes (micro/occult or macro/clinically overt)
* Non-ulcerated or unknown primary melanoma with one macro/clinically overt lymph node metastasis, including a single matted nodal mass

* No non-ulcerated or unknown primary tumor and a single micrometastatic lymph node
* Non-ulcerated melanoma with two or more lymph node metastases (micro/occult or macro/clinically overt) and/or matted nodes
* Any satellite/in transit metastasis with or without lymph node involvement
* Patients with recurrent disease must have recurrent disease in the regional nodal basin of a prior complete lymphadenectomy
* Multiple regional nodal basin involvement allowed if they are appropriate anatomic drainage basins for primary site
* Patients must be disease free at time of enrollment based on the following surgical criteria:

* Patients at initial presentation of melanoma must undergo adequate wide excision of primary lesion
* Patients with previously diagnosed melanoma must have all disease resected with pathologically negative margins and no disease at primary site or second resection of primary
* Full lymphadenectomy required of all patients including those with positive sentinel nodes or positive satellite/in-transit metastasis
* No more than 56 days since prior lymphadenectomy OR surgery to remove recurrent disease after prior complete lymphadenectomy
* Must be willing to participate in minimal residual disease studies if registered on the study on 3/1/2003 or later

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Zubrod 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Absolute granulocyte count at least 1,500/mm^3
* Platelet count at least 100,000/mm^3

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 2 times ULN
* LDH and alkaline phosphatase no greater than 2 times ULN (above normal value requires a contrast-enhanced CT scan or MRI of liver)
* No known recent hepatitis positivity by PCR

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 75 mL/min

Cardiovascular:

* No congestive heart failure
* No coronary artery disease
* No serious cardiac arrhythmia
* No prior myocardial infarction
* Normal cardiac stress test required if any of the following are present:

* Over age 50
* Abnormal EKG
* History of cardiac disease

Pulmonary:

* No symptomatic pulmonary disease

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No autoimmune disorders or conditions of immunosuppression
* No other prior malignancy within the past 5 years except the following:

* Adequately treated basal cell or squamous cell skin cancer
* Carcinoma in situ of the cervix
* Adequately treated stage I or II cancer in remission
* HIV negative
* No known AIDS or HIV-1 associated complex

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior immunotherapy, including interferon, interleukin, levamisole, or other biologic response modifiers
* No other concurrent biologic therapy

Chemotherapy:

* No prior chemotherapy (including infusion or perfusion therapy)
* No other concurrent chemotherapy

Endocrine therapy:

* No concurrent systemic corticosteroids or topical steroid creams
* Concurrent steroid antihistamines allowed if no alternative
* No concurrent hormonal therapy

Radiotherapy:

* No prior radiotherapy

* Prior postlumpectomy radiotherapy for breast cancer allowed
* No concurrent radiotherapy

Surgery:

* See Disease Characteristics
* No concurrent surgery

Other:

* No concurrent anti-hypertensive medications (arm II only)
* No concurrent immunosuppressive agents
* No other concurrent anticancer therapy
* Antihistamines allowed if no alternative medication suitable
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA,NSW,VIC
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment hospital [2] 0 0
Sanofi-Aventis Administrative Office - Macquarie Park
Recruitment hospital [3] 0 0
Westmead Institute for Cancer Research at Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Novartis Investigative Site - Concord
Recruitment hospital [5] 0 0
Novartis Investigative Site - Fitzroy
Recruitment hospital [6] 0 0
Novartis Investigative site - Geelong
Recruitment hospital [7] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [8] 0 0
Novartis Investigative site - Maroochydore
Recruitment hospital [9] 0 0
Novartis Investigative site - Nedlands
Recruitment hospital [10] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [11] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [12] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [13] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment postcode(s) [2] 0 0
- Macquarie Park
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
- Concord
Recruitment postcode(s) [5] 0 0
- Fitzroy
Recruitment postcode(s) [6] 0 0
- Geelong
Recruitment postcode(s) [7] 0 0
- Kogarah
Recruitment postcode(s) [8] 0 0
- Maroochydore
Recruitment postcode(s) [9] 0 0
- Nedlands
Recruitment postcode(s) [10] 0 0
3052 - Parkville
Recruitment postcode(s) [11] 0 0
- Adelaide
Recruitment postcode(s) [12] 0 0
- Melbourne
Recruitment postcode(s) [13] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Idaho
Country [12] 0 0
United States of America
State/province [12] 0 0
Illinois
Country [13] 0 0
United States of America
State/province [13] 0 0
Indiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Iowa
Country [15] 0 0
United States of America
State/province [15] 0 0
Kansas
Country [16] 0 0
United States of America
State/province [16] 0 0
Louisiana
Country [17] 0 0
United States of America
State/province [17] 0 0
Maryland
Country [18] 0 0
United States of America
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Massachusetts
Country [19] 0 0
United States of America
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Michigan
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United States of America
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Minnesota
Country [21] 0 0
United States of America
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Missouri
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United States of America
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Montana
Country [23] 0 0
United States of America
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Nebraska
Country [24] 0 0
United States of America
State/province [24] 0 0
New Hampshire
Country [25] 0 0
United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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North Dakota
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United States of America
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Ohio
Country [31] 0 0
United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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South Dakota
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United States of America
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Tennessee
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United States of America
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Texas
Country [37] 0 0
United States of America
State/province [37] 0 0
Utah
Country [38] 0 0
United States of America
State/province [38] 0 0
Virginia
Country [39] 0 0
United States of America
State/province [39] 0 0
Washington
Country [40] 0 0
United States of America
State/province [40] 0 0
West Virginia
Country [41] 0 0
United States of America
State/province [41] 0 0
Wisconsin
Country [42] 0 0
United States of America
State/province [42] 0 0
Wyoming
Country [43] 0 0
Argentina
State/province [43] 0 0
Buenos Aires
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Austria
State/province [44] 0 0
Vienna
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Belgium
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Diegem
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Bosnia and Herzegovina
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Sarajevo
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Brazil
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Sao Paulo
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Bulgaria
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Vazrjdane Region
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Canada
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Québec
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Colombia
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Bogota
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Croatia
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Zagreb
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Czech Republic
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Praha
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Egypt
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Cairo
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Estonia
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Tallin
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France
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Paris
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Germany
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Frankfurt
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Greece
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Kallithea
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Hong Kong
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Hong Kong
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Hungary
State/province [59] 0 0
Budapest
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India
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Mumbai
Country [61] 0 0
Ireland
State/province [61] 0 0
Dublin
Country [62] 0 0
Israel
State/province [62] 0 0
Natanya
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Italy
State/province [63] 0 0
Milan
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Seoul
Country [65] 0 0
Lebanon
State/province [65] 0 0
Beirut
Country [66] 0 0
Mexico
State/province [66] 0 0
Col. Coyoacan
Country [67] 0 0
New Zealand
State/province [67] 0 0
Macquarie Park
Country [68] 0 0
Poland
State/province [68] 0 0
Warsaw
Country [69] 0 0
Romania
State/province [69] 0 0
Bucuresti
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Moscow
Country [71] 0 0
Slovakia
State/province [71] 0 0
Bratislava
Country [72] 0 0
Slovenia
State/province [72] 0 0
Ljubljana
Country [73] 0 0
South Africa
State/province [73] 0 0
Gauteng
Country [74] 0 0
Spain
State/province [74] 0 0
Barcelona
Country [75] 0 0
Sweden
State/province [75] 0 0
Bromma
Country [76] 0 0
Switzerland
State/province [76] 0 0
Genève
Country [77] 0 0
Taiwan
State/province [77] 0 0
Taipei
Country [78] 0 0
Tunisia
State/province [78] 0 0
Megrine
Country [79] 0 0
Turkey
State/province [79] 0 0
Istanbul
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Guildford Surrey
Country [81] 0 0
Uruguay
State/province [81] 0 0
Montevideo
Country [82] 0 0
Venezuela
State/province [82] 0 0
Caracas
Country [83] 0 0
United States of America
State/province [83] 0 0
Hawaii
Country [84] 0 0
United States of America
State/province [84] 0 0
Kentucky
Country [85] 0 0
United States of America
State/province [85] 0 0
Maine
Country [86] 0 0
United States of America
State/province [86] 0 0
Mississippi
Country [87] 0 0
United States of America
State/province [87] 0 0
Oklahoma
Country [88] 0 0
United States of America
State/province [88] 0 0
Vermont
Country [89] 0 0
Canada
State/province [89] 0 0
Alberta
Country [90] 0 0
Canada
State/province [90] 0 0
British Columbia
Country [91] 0 0
Canada
State/province [91] 0 0
Manitoba
Country [92] 0 0
Canada
State/province [92] 0 0
Ontario
Country [93] 0 0
Canada
State/province [93] 0 0
Quebec
Country [94] 0 0
Canada
State/province [94] 0 0
Saskatchewan
Country [95] 0 0
Switzerland
State/province [95] 0 0
Geneva
Country [96] 0 0
United States of America
State/province [96] 0 0
Rhode Island
Country [97] 0 0
Canada
State/province [97] 0 0
Calgary
Country [98] 0 0
Canada
State/province [98] 0 0
London
Country [99] 0 0
Canada
State/province [99] 0 0
Montreal
Country [100] 0 0
Canada
State/province [100] 0 0
Ste-Foy
Country [101] 0 0
Canada
State/province [101] 0 0
Toronto
Country [102] 0 0
New Zealand
State/province [102] 0 0
Auckland
Country [103] 0 0
New Zealand
State/province [103] 0 0
Christchurch
Country [104] 0 0
Spain
State/province [104] 0 0
Salamanca
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Liverpool
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Manchester
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Nottingham
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Oxford
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Penarth
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Pernarth
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Stanmore
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Vale of Glamorgan

Funding & Sponsors
Primary sponsor type
Other
Name
SWOG Cancer Research Network
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Eastern Cooperative Oncology Group
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Cancer and Leukemia Group B
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Children's Oncology Group
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Cancer International Research Group (CIRG)
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Children's Oncology Group
Country [6] 0 0
Other collaborator category [7] 0 0
Government body
Name [7] 0 0
National Cancer Institute (NCI)
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Children's Oncology Group
Country [8] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lawrence E. Flaherty, MD
Address 0 0
Barbara Ann Karmanos Cancer Institute
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents