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Trial registered on ANZCTR


Registration number
ACTRN12610000845033
Ethics application status
Approved
Date submitted
17/06/2010
Date registered
7/10/2010
Date last updated
9/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective, randomized phase III study of two intensified treatment groups [Methotrexate/Vinblastine/Adriamycin/Cisplatin (MVAC) vs. Gemcitabine/Cisplatin] in patients with inoperable or recurrent urothelial cancer
Scientific title
Prospective, randomized phase III study to compare survival between two intensified treatment groups (Methotrexate/Vinblastine/Adriamycin/Cisplatin (MVAC) vs. Gemcitabine/Cisplatin) in patients with inoperable or recurrent urothelial cancer
Secondary ID [1] 251863 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urothelial cancer 257462 0
Condition category
Condition code
Cancer 257610 257610 0 0
Bladder

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gemcitabine 2500mg/m^2 intravenously infused (iv) over 30 min (day 1) immediately followed by Cisplatin 70mg/m^2 iv over 60 min (day 1)

Gemcitabine is administered before Cisplatin.

Treatment will be repeated every 2 weeks for a minimum of 6 cycles unless disease progression or intolerability. Maximum number of cycles 12
Intervention code [1] 256656 0
Treatment: Drugs
Comparator / control treatment
Methotrexate 30mg/m^2 intravenous (iv) day 1
Vinblastine 3mg/m^2 intravenous (iv) day 1
Adriamycin 30mg/m^2 intravenous (iv) day 1
Cisplatin 70mg/m^2 intravenous (iv) day 1

Methotrexate, Vinblastine and Adriamycin were administered as intravenous bolus infusions immediately followed by intravenous infusion of cisplatin over 60 min.

Treatment will be repeated every 2 weeks for a minimum of 6 cycles unless disease progression or intolerability. Maximum number of cycles 12
Control group
Active

Outcomes
Primary outcome [1] 258616 0
To compare survival time from randomization to death from any cause between the two intensified treatment groups (MVAC vs Gemcitabine/Cisplatin).
Timepoint [1] 258616 0
6 years after study initiation. This assessement will be done using clinical data records
Secondary outcome [1] 264540 0
To compare the TTP (Time To Progression) between the two groups
Timepoint [1] 264540 0
Evaluation of disease will be performed every 6 cycles of chemotherapy with computed tomographies (CTs) and bone scan/magnetic resonance imaging(MRI) if indicated. Intermediate evaluation will be performed only in case of clinical deterioration and signs of progression. After treatment completion, patients will be evaluated every 3 months for the first 2 years, every 4 months for the next 2 years and every 6 months thereafter for up to 6 years.
Secondary outcome [2] 264541 0
To compare the RR (Response Rate) between the two groups
Timepoint [2] 264541 0
The evaluation of response will be performed every 6 cycles of chemotherapy using the RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
Secondary outcome [3] 264542 0
To compare the toxicity profile between the two groups
Timepoint [3] 264542 0
Complete Blood Count, biochemistry, electrocardiogram (ECG) and triplex will be performed before initiation of treatment. Toxicity is assessed by laboratory evaluation of hematology and biochemistry, ECG etc after each cycle (triplex will be performed only in case of need). Complete toxicity evaluation will be performed at the end of treatment (1 month after the last administration of the drug)

Eligibility
Key inclusion criteria
1. Histologically confirmed inoperable or recurrent transitional cell advanced urothelial cancer
2. Age of >18 years
3. Life expectancy > 3 months
4. No prior chemotherapy for advanced disease is allowed
5. Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1
6. Creatinine clearance > 50 ml/min (Cockroft Formula)
7. Absolute Neutrophil Count (ANC)>= 1,500 /Microlitre (microL), platelets>= 100,000 /microL, bilirubin and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <2N
8. Absence of cardiac failure. Patients previously treated with adriamycin are excluded from the study. Patients with cardiac disease should demonstrate a baseline left ventricular ejection fraction (LVEF) >50%
9. Signed Informed Consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Other histology types of urothelial cancer. Mixed histology types mainly of transitional cell cancer are allowed.
2.History of other neoplasm within the 5 last years except for radically excised basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix.
3.Prior adjuvant or neo-adjuvant chemotherapy containing adriamycin. Patients who received adjuvant or neo-adjuvant chemotherapy with Gemcitabine/Cisplatin or Gemcitabine/Carboplatin within the last 12 months are excluded.
4.Any active infection or other uncontrolled underlying condition (infection, cardiac arrythmia, diabetes mellitus)
5.Women of reproductive age should obtain a negative pregnancy test. All sexually active patients should take efficient contraceptive measures.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/12/2003
Actual
11/11/2003
Date of last participant enrolment
Anticipated
Actual
23/01/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
206
Accrual to date
Final
Recruitment outside Australia
Country [1] 2669 0
Greece
State/province [1] 2669 0

Funding & Sponsors
Funding source category [1] 257134 0
Other Collaborative groups
Name [1] 257134 0
Hellenic Cooperative Oncology Group
Country [1] 257134 0
Greece
Primary sponsor type
Other Collaborative groups
Name
Hellenic Cooperative Oncology Group
Address
18, Hatzikostandi str, 11524, Athens
Country
Greece
Secondary sponsor category [1] 256391 0
None
Name [1] 256391 0
Address [1] 256391 0
Country [1] 256391 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 31220 0
Prof Meletios-Athanassios Dimopoulos
Address 31220 0
Department of Clinical Tharepeutics, Alexandra Hospital, 80 Vas. Sofias Av, 11528, Athens
Country 31220 0
Greece
Phone 31220 0
+302103381392
Fax 31220 0
Email 31220 0
mdimop@med.uoa.gr
Contact person for public queries
Name 14467 0
Eleni Papakostaki
Address 14467 0
Hellenic Cooperative Oncology Group, 18, Hatzikostandi str, 11524, Athens
Country 14467 0
Greece
Phone 14467 0
+302106912520
Fax 14467 0
+302106912713
Email 14467 0
e_papakostaki@hecog.ondsl.gr
Contact person for scientific queries
Name 5395 0
Aristotelis Bamias
Address 5395 0
Department of Clinical Tharepeutics, Alexandra Hospital, 80 Vas. Sofias Av, 11528, Athens
Country 5395 0
Greece
Phone 5395 0
+302103381546
Fax 5395 0
+302103381511
Email 5395 0
abamias@med.uoa.gr

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.