A Phase 3 interventional study of doxorubicin hydrochloride and gemcitabine hydrochloride in Stage III Bladder Cancer, Stage IV Bladder Cancer and Transitional Cell Carcinoma of the Bladder, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed. Per ClinicalTrials.gov, last updated 2016-08-02.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 3, Interventional, and Treatment
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. 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.
PRIMARY OBJECTIVES:
I. Compare the overall and progression-free survival of patients with stage III or IV transitional cell carcinoma of the bladder urothelium treated with immediate versus deferred adjuvant chemotherapy after radical cystectomy.
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.
ARM I: Beginning within 90 days of radical cystectomy, patients receive a total of 4 courses of adjuvant chemotherapy.
ARM II: Beginning at the time of clinical relapse, patients receive a total of 6 courses of adjuvant chemotherapy.
Patients in both arms receive one of the following chemotherapy regimens to be determined by participating center:
REGIMEN A (Classical M-VAC): 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.
REGIMEN B (High-dose M-VAC): 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.
REGIMEN C (Gemcitabine and cisplatin): 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.
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 and EORTC.
1,649 studies on the registry are indexed under Urinary Bladder Neoplasms; 427 are open to participants now.
This study's enrollment of 285 is above the median of 60 across 1,183 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 352 studies on the registry; 23 are open to participants now.
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Inclusion Criteria:
Histologically confirmed transitional cell carcinoma of the bladder urothelium
Beginning within 90 days of radical cystectomy, patients receive a total of 4 courses of adjuvant chemotherapy.
Drug: doxorubicin hydrochloride · Drug: gemcitabine hydrochloride · Drug: vinblastine sulfate · Drug: methotrexate · Drug: cisplatin · Biological: filgrastim
Beginning at the time of clinical relapse, patients receive a total of 6 courses of adjuvant chemotherapy.
Drug: doxorubicin hydrochloride · Drug: gemcitabine hydrochloride · Drug: vinblastine sulfate · Drug: methotrexate · Drug: cisplatin · Biological: filgrastim
Given IV
Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Given IV
Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Given IV
Also known as: 29060-LE, Exal, Velban, Velbe, Velsar
Given IV
Also known as: amethopterin, Folex, methylaminopterin, Mexate, MTX
Given IV
Also known as: CACP, CDDP, CPDD, DDP
Given SC
Also known as: G-CSF, Neupogen
Duration of survival
Estimated using the Kaplan-Meier technique and compared based on a two sided logrank test with retrospective stratification for the participating cooperative group, the chemotherapy regimen, the T category and the nodal status.
Time frame: 5 years
Duration of progression-free survival
Estimated using the Kaplan-Meier technique and compared based on a two sided logrank test with retrospective stratification for the participating cooperative group, the chemotherapy regimen, the T category and the nodal status.
Time frame: 5 years
No study locations are listed for this record.
The record gives a start of Oct 2001, a primary completion of Jan 2014 and a completion of Jul 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Doxorubicin · Gemcitabine · Vinblastine · Methotrexate · Cisplatin · Filgrastim
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