Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborators: Arbeitsgemeinschaft Urologische Onkologie; Groupe D'Etude des Tumeurs Uro-Genitales; Institute of Cancer Research, United Kingdom; National Cancer Institute (NCI); NCIC Clinical Trials Group
• Treatments: Doxorubicin; Gemcitabine; Liposomal doxorubicin; Methotrexate; Vinblastine

Criteria

Inclusion Criteria:

• Histologically confirmed transitional cell carcinoma of the bladder urothelium

• T3-4, N1-3, M0

• No pure squamous cell or adenocarcinoma tumors

• No more than 90 days since prior radical cystectomy and bilateral lymphadenectomy without evidence of microscopic residual disease

• Performance status - WHO 0-1

• WBC at least 3,500/mm^3

• Platelet count at least 120,000/mm^3

• SGOT/SGPT less than 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase less than 2.5 times ULN

• Bilirubin normal

• Glomerular filtration rate greater than 60 mL/min

• No clinically significant cardiac arrhythmia

• No congestive heart failure

• No complete bundle branch block

• No New York Heart Association class III or IV heart disease

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for 6 months after study

• Considered fit for cisplatin-containing combination chemotherapy

• No clinically abnormal auditory function

• No known hypersensitivity to E. coli-derived drug preparations

• No grade 2 or greater peripheral neuropathy

• No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix, treated basal cell skin cancer, or treated incidental prostate cancer (pT2, Gleason score no greater than 6, and PSA less than 0.5 ng/mL)

• No psychological, familial, sociological, or geographical condition that would preclude study involvement

• No prior systemic chemotherapy

• No prior radiotherapy to the bladder