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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00085098




Registration number
NCT00085098
Ethics application status
Date submitted
10/06/2004
Date registered
11/06/2004
Date last updated
7/09/2018

Titles & IDs
Public title
Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Primary Central Nervous System (CNS) Germ Cell Tumor
Scientific title
Radiotherapy Alone Versus Chemotherapy Followed By Response-Based Radiotherapy For Newly Diagnosed Primary CNS Germinoma
Secondary ID [1] 0 0
CDR0000367294
Secondary ID [2] 0 0
ACNS0232
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Tumor 0 0
Central Nervous System Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Children's - Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - filgrastim
Treatment: Drugs - carboplatin
Treatment: Drugs - cisplatin
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - etoposide
Treatment: Other - radiation therapy

Experimental: Regimen A (radiotherapy only) - Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.

Experimental: Regimen B (chemotherapy plus radiotherapy) - Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.

Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.

Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF), subcutaneous (SC) or IV beginning on day 4 and continuing until blood counts recover.

Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or progressive disease (PD) are restaged and may undergo standard radiation therapy as in regimen A. Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks


Treatment: Other: filgrastim
Given by infusion or injection

Treatment: Drugs: carboplatin
Given IV over 1 hour

Treatment: Drugs: cisplatin
Given IV over 6 hours

Treatment: Drugs: cyclophosphamide
Given IV over 1 hour

Treatment: Drugs: etoposide
Given IV over 2 hours

Treatment: Other: radiation therapy
Patients undergo radiotherapy 5 days a week
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
Event-free Survival
Timepoint [1] 0 0
Study enrollment until date of earliest qualifying event (QE), date last known to be QE-free if the patient is followed for less than three years and is QE-free at the time of analysis, or 3 years if the patient is QE-free at 3 years
Secondary outcome [1] 0 0
Number of Participants With a Response to Regimen B
Timepoint [1] 0 0
5 years from beginning of treatment
Secondary outcome [2] 0 0
Toxicity and Safety as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Timepoint [2] 0 0
From the beginning of treatment, assessed up to 5 years
Secondary outcome [3] 0 0
Quality of Life (QOL) and Neurocognitive Assessment (NP)
Timepoint [3] 0 0
2 years from beginning of treatment

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically confirmed primary CNS pure germ cell tumor

* Diagnosed within the past 31 days
* Meets any 1 OR none (i.e., M0 [localized disease]) of the following staging criteria:

* M+ (disseminated disease)

* Leptomeningeal or intraventricular metastases visualized on MRI scans of the brain and spine
* Clumps of tumor cells on lumbar cerebrospinal fluid (CSF) cytology
* Visible tumor studding the walls of the lateral or third ventricles noted during endoscopy or surgery
* Primary tumor arising within the parenchyma of the brain, brainstem, or spinal cord
* Measurable multi-focal tumors arising in both the pineal and suprasellar regions (i.e., multiple midline tumors)
* Infiltrative, intra-axial extension on brain MRI > 1 cm beyond enhancing tumor
* Modified M+ (occult multi-focal disease)

* M0 at diagnosis with a localized pineal region tumor with signs and symptoms of diabetes insipidus without measurable disease in the suprasellar region
* Lumbar CSF assay meeting criteria for the following marker profiles:

* Serum and CSF beta human chorionic gonadotropin (ß-HCG) = 50 IU/dL
* Serum alpha fetoprotein (AFP) = 10 IU/L AND = institutional norm
* CSF AFP = 2.0 IU/L AND = institutional norm

PATIENT CHARACTERISTICS:

Age

* 3 to 25

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count > 1,000/mm^3
* Platelet count > 100,000/mm^3 (transfusion independent)
* Hemoglobin > 10.0 g/dL (transfusion allowed)

Hepatic

* Bilirubin = 1.5 times upper limit of normal (ULN)
* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 times ULN

Renal

* Creatinine adjusted according to age as follows*:

* No greater than 0.4 mg/dL (= 5 months)
* No greater than 0.5 mg/dL (6 months -11 months)
* No greater than 0.6 mg/dL (1 year-23 months)
* No greater than 0.8 mg/dL (2 years-5 years)
* No greater than 1.0 mg/dL (6 years-9 years)
* No greater than 1.2 mg/dL (10 years-12 years)
* No greater than 1.4 mg/dL (13 years and over [female])
* No greater than 1.5 mg/dL (13 years to 15 years [male])
* No greater than 1.7 mg/dL (16 years and over [male]) AND
* Creatinine clearance OR radioisotope glomerular filtration rate > 70 mL/min

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Euthyroid (with or without levothyroxine sodium therapy) as determined by normal T4 ± thyroid-stimulating hormone levels*
* Diabetes insipidus allowed provided patient is relatively stable on desmopressin acetate
* Normal endogenous cortisol function*
* Adequate antidiuretic hormone reserves* NOTE: *Unless receiving replacement therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Concurrent replacement hormones allowed (e.g., corticosteroids, levothyroxine sodium, and desmopressin acetate)

Radiotherapy

* Not specified

Surgery

* Prior surgery for germ cell tumor allowed

Other

* No other prior therapy for germ cell tumor
* Concurrent anticonvulsants allowed
Minimum age
3 Years
Maximum age
25 Years
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
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2009
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [2] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [3] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment postcode(s) [3] 0 0
6001 - 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
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maine
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
Country [17] 0 0
United States of America
State/province [17] 0 0
Massachusetts
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
State/province [19] 0 0
Minnesota
Country [20] 0 0
United States of America
State/province [20] 0 0
Mississippi
Country [21] 0 0
United States of America
State/province [21] 0 0
Missouri
Country [22] 0 0
United States of America
State/province [22] 0 0
Nevada
Country [23] 0 0
United States of America
State/province [23] 0 0
New Jersey
Country [24] 0 0
United States of America
State/province [24] 0 0
New Mexico
Country [25] 0 0
United States of America
State/province [25] 0 0
New York
Country [26] 0 0
United States of America
State/province [26] 0 0
North Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Ohio
Country [28] 0 0
United States of America
State/province [28] 0 0
Oklahoma
Country [29] 0 0
United States of America
State/province [29] 0 0
Oregon
Country [30] 0 0
United States of America
State/province [30] 0 0
Pennsylvania
Country [31] 0 0
United States of America
State/province [31] 0 0
Rhode Island
Country [32] 0 0
United States of America
State/province [32] 0 0
South Carolina
Country [33] 0 0
United States of America
State/province [33] 0 0
South Dakota
Country [34] 0 0
United States of America
State/province [34] 0 0
Tennessee
Country [35] 0 0
United States of America
State/province [35] 0 0
Texas
Country [36] 0 0
United States of America
State/province [36] 0 0
Utah
Country [37] 0 0
United States of America
State/province [37] 0 0
Washington
Country [38] 0 0
United States of America
State/province [38] 0 0
West Virginia
Country [39] 0 0
United States of America
State/province [39] 0 0
Wisconsin
Country [40] 0 0
Canada
State/province [40] 0 0
Alberta
Country [41] 0 0
Canada
State/province [41] 0 0
British Columbia
Country [42] 0 0
Canada
State/province [42] 0 0
Manitoba
Country [43] 0 0
Canada
State/province [43] 0 0
Newfoundland and Labrador
Country [44] 0 0
Canada
State/province [44] 0 0
Ontario
Country [45] 0 0
Canada
State/province [45] 0 0
Quebec
Country [46] 0 0
Puerto Rico
State/province [46] 0 0
Santurce

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Jeffrey C. Allen, MD
Address 0 0
NYU Langone Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00085098