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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
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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
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Secondary ID [1]
251863
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
urothelial cancer
257462
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Condition category
Condition code
Cancer
257610
257610
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0
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Bladder
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
256656
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Treatment: Drugs
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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
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Control group
Active
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Outcomes
Primary outcome [1]
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To compare survival time from randomization to death from any cause between the two intensified treatment groups (MVAC vs Gemcitabine/Cisplatin).
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Assessment method [1]
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Timepoint [1]
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6 years after study initiation. This assessement will be done using clinical data records
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Secondary outcome [1]
264540
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To compare the TTP (Time To Progression) between the two groups
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Assessment method [1]
264540
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Timepoint [1]
264540
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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.
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Secondary outcome [2]
264541
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To compare the RR (Response Rate) between the two groups
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Assessment method [2]
264541
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Timepoint [2]
264541
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The evaluation of response will be performed every 6 cycles of chemotherapy using the RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
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Secondary outcome [3]
264542
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To compare the toxicity profile between the two groups
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Assessment method [3]
264542
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Timepoint [3]
264542
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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)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
7/12/2003
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Actual
11/11/2003
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Date of last participant enrolment
Anticipated
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Actual
23/01/2008
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
206
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
2669
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Greece
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State/province [1]
2669
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Funding & Sponsors
Funding source category [1]
257134
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Other Collaborative groups
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Name [1]
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Hellenic Cooperative Oncology Group
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Address [1]
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18, Hatzikostandi str, 11524, Athens
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Country [1]
257134
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Greece
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Primary sponsor type
Other Collaborative groups
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Name
Hellenic Cooperative Oncology Group
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Address
18, Hatzikostandi str, 11524, Athens
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Country
Greece
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Secondary sponsor category [1]
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None
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Name [1]
256391
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Address [1]
256391
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Country [1]
256391
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
This is a 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. The primary outcome is to compare the survival between the two groups. The secondary outcomes are to compare the Time to Progression, Response Rate and Toxicity between the two groups.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Meletios-Athanassios Dimopoulos
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Address
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Department of Clinical Tharepeutics, Alexandra Hospital, 80 Vas. Sofias Av, 11528, Athens
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Country
31220
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Greece
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Phone
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+302103381392
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Fax
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Email
31220
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[email protected]
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Contact person for public queries
Name
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Ms Eleni Papakostaki
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Address
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Hellenic Cooperative Oncology Group, 18, Hatzikostandi str, 11524, Athens
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Country
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Greece
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Phone
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+302106912520
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Fax
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+302106912713
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Aristotelis Bamias
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Address
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Department of Clinical Tharepeutics, Alexandra Hospital, 80 Vas. Sofias Av, 11528, Athens
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Country
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Greece
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Phone
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+302103381546
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Fax
5395
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+302103381511
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Email
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[email protected]
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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.
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