Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
- Conditions
- Bladder Cancer
- Registration Number
- NCT00024349
- Lead Sponsor
- University Hospital Birmingham
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Loco-regional disease free survival at 2 years
- Secondary Outcome Measures
Name Time Method 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 Rate of salvage cystectomy Acute toxicity and cystoscopic local control at 3 months, 1 year, and 2 years Overall survival
Trial Locations
- Locations (27)
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
🇬🇧Birmingham, England, United Kingdom
St. Thomas' Hospital
🇬🇧London, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
🇬🇧Sutton, England, United Kingdom
Southend University Hospital NHS Foundation Trust
🇬🇧Westcliff-On-Sea, England, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil, England, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Royal United Hospital
🇬🇧Bath, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Essex County Hospital
🇬🇧Colchester, England, United Kingdom
Derbyshire Royal Infirmary
🇬🇧Derby, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, England, United Kingdom
Worthing Hospital
🇬🇧Worthing, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Royal Shrewsbury Hospital
🇬🇧Shrewsbury, England, United Kingdom
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
🇬🇧Hull, England, United Kingdom
Good Hope Hospital Trust
🇬🇧West Midlands, England, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
Glan Clwyd Hospital
🇬🇧Rhyl, Wales, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Royal Bournemouth Hospital NHS Trust
🇬🇧Bournemouth, England, United Kingdom
Northampton General Hospital NHS Trust
🇬🇧Northampton, England, United Kingdom
Torbay Hospital
🇬🇧Torquay, England, United Kingdom