Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy such as fluorouracil and mitomycin use different ways to stop tumor cells from dividing so they stop growing or die. Fluorouracil and mitomycin may make the tumor cells more sensitive to radiation therapy. It is not yet known if radiation therapy is more effective with or without chemotherapy in treating bladder cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to all or part of the bladder with or without chemotherapy in treating patients who have stage II or stage III bladder cancer.
Drug: mitomycin C
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||2X2 Factorial Randomized Phase III Study Comparing Standard Versus Reduced Volume Radiotherapy With and Without Synchronous Chemotherapy in Muscle Invasive Bladder Cancer|
- Loco-regional disease free survival at 2 years [ Designated as safety issue: No ]
- Disease-free survival, metastases-free survival, and late toxicity by RTOG and Lent Som toxicity scores, Bladder capacity, and patient assessed Fact-BL quality of life scores at 1 and 2 years [ Designated as safety issue: Yes ]
- Acute toxicity and cystoscopic local control at 3 months, 1 year, and 2 years [ Designated as safety issue: Yes ]
- Rate of salvage cystectomy [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||June 2001|
|Study Completion Date:||April 2012|
- Compare the efficacy of standard volume radiotherapy vs reduced volume radiotherapy with or without synchronous fluorouracil and mitomycin in patients with stage II or III (muscle invasive) bladder cancer.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, prior neoadjuvant chemotherapy (yes vs no), and intent to enter only 1 of the possible 2 randomizations on study (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients undergo standard radiotherapy once daily 5 days a week for 4 or 6.5 weeks. Patients also receive synchronous chemotherapy comprising mitomycin IV on day 1 and fluorouracil IV continuously over days 1-5 and 16-20 during radiotherapy.
- Arm II: Patients undergo standard radiotherapy as in arm I (without chemotherapy).
If standard radiotherapy is clearly indicated (e.g., patients with multiple tumors) patients may be randomized to standard radiotherapy with or without chemotherapy (arms I or III above). If chemotherapy is clearly contraindicated, patients are randomized to standard or reduced volume radiotherapy without chemotherapy (arms III or IV above).
Quality of life is assessed at baseline, at the end of therapy, at 6 and 12 months post-randomization, and then annually for at least 5 years.
Patients are followed at 6, 9, and 12 months post-randomization and then at least annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024349
|Royal United Hospital|
|Bath, England, United Kingdom, BA1 3NG|
|Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust|
|Birmingham, England, United Kingdom, B15 2TH|
|Royal Bournemouth Hospital NHS Trust|
|Bournemouth, England, United Kingdom, BH7 7DW|
|Sussex Cancer Centre at Royal Sussex County Hospital|
|Brighton, England, United Kingdom, BN2 5BF|
|Bristol Haematology and Oncology Centre|
|Bristol, England, United Kingdom, BS2 8ED|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Cheltenham General Hospital|
|Cheltenham, England, United Kingdom, GL53 7AN|
|Essex County Hospital|
|Colchester, England, United Kingdom, C03 3NB|
|Coventry, England, United Kingdom, CV2 2DX|
|Derbyshire Royal Infirmary|
|Derby, England, United Kingdom, DE1 2QY|
|Royal Devon and Exeter Hospital|
|Exeter, England, United Kingdom, EX2 5DW|
|St. Luke's Cancer Centre at Royal Surrey County Hospital|
|Guildford, England, United Kingdom, GU2 7XX|
|Princess Royal Hospital at Hull and East Yorkshire NHS Trust|
|Hull, England, United Kingdom, HU8 9HE|
|St. Thomas' Hospital|
|London, England, United Kingdom, SE1 9RT|
|Maidstone, England, United Kingdom, ME16 9QQ|
|Clatterbridge Centre for Oncology|
|Merseyside, England, United Kingdom, CH63 4JY|
|James Cook University Hospital|
|Middlesbrough, England, United Kingdom, TS4 3BW|
|Northern Centre for Cancer Treatment at Newcastle General Hospital|
|Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE|
|Northampton General Hospital NHS Trust|
|Northampton, England, United Kingdom, NN1 5BD|
|Royal Shrewsbury Hospital|
|Shrewsbury, England, United Kingdom, SY3 8XQ|
|Royal Marsden NHS Foundation Trust - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Torquay, England, United Kingdom, TQ2 7AA|
|Good Hope Hospital Trust|
|West Midlands, England, United Kingdom, B75 7RR|
|Southend University Hospital NHS Foundation Trust|
|Westcliff-On-Sea, England, United Kingdom, SS0 0RY|
|Worthing, England, United Kingdom, BN11 2DH|
|Yeovil District Hospital|
|Yeovil, England, United Kingdom, BA21 4AT|
|Glan Clwyd Hospital|
|Rhyl, Wales, United Kingdom, LL18 5UG|
|Study Chair:||Nicholas D. James, MD||University Hospital Birmingham|