Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer

December 17, 2013 updated by: University Hospital Birmingham

2X2 Factorial Randomized Phase III Study Comparing Standard Versus Reduced Volume Radiotherapy With and Without Synchronous Chemotherapy in Muscle Invasive 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Bath, England, United Kingdom, BA1 3NG
        • Royal United Hospital
      • Birmingham, England, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
      • Bournemouth, England, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital NHS Trust
      • Brighton, England, United Kingdom, BN2 5BF
        • Sussex Cancer Centre at Royal Sussex County Hospital
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital
      • Cheltenham, England, United Kingdom, GL53 7AN
        • Cheltenham General Hospital
      • Colchester, England, United Kingdom, C03 3NB
        • Essex County Hospital
      • Coventry, England, United Kingdom, CV2 2DX
        • Walsgrave Hospital
      • Derby, England, United Kingdom, DE1 2QY
        • Derbyshire Royal Infirmary
      • Exeter, England, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Guildford, England, United Kingdom, GU2 7XX
        • St. Luke's Cancer Centre at Royal Surrey County Hospital
      • Hull, England, United Kingdom, HU8 9HE
        • Princess Royal Hospital at Hull and East Yorkshire NHS Trust
      • London, England, United Kingdom, SE1 9RT
        • St. Thomas' Hospital
      • Maidstone, England, United Kingdom, ME16 9QQ
        • Maidstone Hospital
      • Merseyside, England, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology
      • Middlesbrough, England, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
        • Northern Centre for Cancer Treatment at Newcastle General Hospital
      • Northampton, England, United Kingdom, NN1 5BD
        • Northampton General Hospital NHS Trust
      • Shrewsbury, England, United Kingdom, SY3 8XQ
        • Royal Shrewsbury Hospital
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden NHS Foundation Trust - Surrey
      • Torquay, England, United Kingdom, TQ2 7AA
        • Torbay Hospital
      • West Midlands, England, United Kingdom, B75 7RR
        • Good Hope Hospital Trust
      • Westcliff-On-Sea, England, United Kingdom, SS0 0RY
        • Southend University Hospital NHS Foundation Trust
      • Worthing, England, United Kingdom, BN11 2DH
        • Worthing Hospital
      • Yeovil, England, United Kingdom, BA21 4AT
        • Yeovil District Hospital
    • Wales
      • Rhyl, Wales, United Kingdom, LL18 5UG
        • Glan Clwyd Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive bladder cancer (T2-4a, N0, M0)

    • Adenocarcinoma
    • Transitional cell carcinoma
    • Squamous cell carcinoma
  • Localized muscle invasion by surgery or imaging

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC greater than 4,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • ALT or AST less than 1.5 times ULN

Renal:

  • Glomerular filtration rate greater than 25 mL/min

Other:

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No inflammatory bowel disease
  • No other prior malignancy within the past 2 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
  • No other prior malignancy or uncontrolled systemic disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to the pelvis

Surgery:

  • See Disease Characteristics
  • No bilateral hip replacements

Other:

  • No concurrent metronidazole during fluorouracil administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Loco-regional disease free survival at 2 years

Secondary Outcome Measures

Outcome Measure
Overall survival
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
Acute toxicity and cystoscopic local control at 3 months, 1 year, and 2 years
Rate of salvage cystectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Birmingham

Investigators

  • Study Chair: Nicholas D. James, MD, University Hospital Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 13, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068921
  • CRC-BC2001
  • EU-20052
  • ISRCTN68324339

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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