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| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Groupe D'Etude des Tumeurs Uro-Genitales Nordic Urothelial Cancer Group NCIC Clinical Trials Group Institute of Cancer Research, United Kingdom American College of Surgeons |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00028756 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known if adjuvant chemotherapy is more effective when given immediately after radical cystectomy (surgery to remove the bladder) or when the cancer returns.
PURPOSE: Randomized phase III trial to compare the effectiveness of immediate adjuvant chemotherapy with that of adjuvant chemotherapy given when the cancer returns in treating patients who have undergone a radical cystectomy for stage III or stage IV transitional cell carcinoma of the bladder urothelium.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Biological: filgrastim Drug: cisplatin Drug: doxorubicin hydrochloride Drug: gemcitabine hydrochloride Drug: methotrexate Drug: vinblastine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Randomized Phase III Trial Comparing Immediate Versus Deferred Chemotherapy After Radical Cystectomy in Patients With pT3-pT4, and/or N+MO Transitional Cell Carcinoma (TCC) of the Bladder |
| Estimated Enrollment: | 660 |
| Study Start Date: | October 2001 |
| Estimated Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Active Comparator
Beginning within 90 days of radical cystectomy, patients receive a total of 4 courses of adjuvant chemotherapy.
|
Biological: filgrastim
Given SC
Drug: cisplatin
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: gemcitabine hydrochloride
Given IV
Drug: methotrexate
Given IV
Drug: vinblastine
Given IV
|
|
Arm II: Experimental
Beginning at the time of clinical relapse, patients receive a total of 6 courses of adjuvant chemotherapy.
|
Biological: filgrastim
Given SC
Drug: cisplatin
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: gemcitabine hydrochloride
Given IV
Drug: methotrexate
Given IV
Drug: vinblastine
Given IV
|
|
Regimen A: Active Comparator
Patients receive classical M-VAC comprising methotrexate IV on days 1, 15, and 22; vinblastine IV on days 2, 15, and 22; and doxorubicin IV and cisplatin IV on day 2. Courses repeat every 28 days.
|
Drug: cisplatin
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: methotrexate
Given IV
Drug: vinblastine
Given IV
|
|
Regimen B: Active Comparator
Patients receive high-dose M-VAC comprising methotrexate IV on day 1 and vinblastine IV, doxorubicin IV, and cisplatin IV on day 2. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 4-10. Courses repeat every 14 days.
|
Biological: filgrastim
Given SC
Drug: cisplatin
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: methotrexate
Given IV
Drug: vinblastine
Given IV
|
|
Regimen C: Active Comparator
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 followed by cisplatin IV on day 1 or 2. Courses repeat every 28 days.
|
Drug: cisplatin
Given IV
Drug: gemcitabine hydrochloride
Given IV
|
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, tumor status (pT1-2 vs pT3 vs pT4), and node status (node positive vs node negative with 15 or more nodes sampled vs node negative with less than 15 nodes sampled). Patients are randomized to one of two treatment arms.
Patients in both arms receive one of the following chemotherapy regimens to be determined by participating center:
Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 660 will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma of the bladder urothelium
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Show 106 Study Locations| Investigator: | Cora N. Sternberg, MD, FACP | Vincenzo Pansadoro Foundation |
| Study Chair: | Christine Theodore, MD | Institut Gustave Roussy |
| Study Chair: | Sten Nilsson, MD | Karolinska University Hospital - Solna |
| Study Chair: | Armen G. Aprikian, MD | Montreal General Hospital |
| Study Chair: | Michael Leahy, MBChB, FRACP, FRCP, FRC Path | Fremantle Hospital |
| Study Chair: | Ian Tannock, MD, PhD | Princess Margaret Hospital, Canada |
More Information
| Responsible Party: | University of Texas Health Science Center at San Antonio ( Charles A. Coltman, Jr ) |
| Study ID Numbers: | CDR0000069130, EORTC-30994, ACOSOG-EORTC-30994, CAN-NCIC-EORTC-30994, FNCLCC-GETUG-EORTC-30994, NORDIC-EORTC-30994, UKCCCR-EORTC-30994, NCRI-BLADDER-EORTC-30994 |
| Study First Received: | January 4, 2002 |
| Last Updated: | October 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00028756 History of Changes |
| Health Authority: | Unspecified |
|
stage III bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Vinblastine Reproductive Control Agents Urologic Neoplasms Carcinoma, Transitional Cell Antibiotics, Antineoplastic Neoplasms by Site Cisplatin |
Urologic Diseases Therapeutic Uses Abortifacient Agents Methotrexate Gemcitabine Dermatologic Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Mitosis Modulators Urinary Bladder Diseases Urinary Bladder Neoplasms Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal |