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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00024349
First received: September 13, 2001
Last updated: December 17, 2013
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Drug: fluorouracil
Drug: mitomycin C
Radiation: radiation therapy
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Loco-regional disease free survival at 2 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 350
Study Start Date: June 2001
Study Completion Date: April 2012
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024349

Locations
United Kingdom
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
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN
Essex County Hospital
Colchester, England, United Kingdom, C03 3NB
Walsgrave Hospital
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 Hospital
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
Torbay Hospital
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 Hospital
Worthing, England, United Kingdom, BN11 2DH
Yeovil District Hospital
Yeovil, England, United Kingdom, BA21 4AT
Glan Clwyd Hospital
Rhyl, Wales, United Kingdom, LL18 5UG
Sponsors and Collaborators
University Hospital Birmingham
Investigators
Study Chair: Nicholas D. James, MD University Hospital Birmingham
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00024349     History of Changes
Other Study ID Numbers: CDR0000068921, CRC-BC2001, EU-20052, ISRCTN68324339
Study First Received: September 13, 2001
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II bladder cancer
stage III bladder cancer
transitional cell carcinoma of the bladder
squamous cell carcinoma of the bladder
adenocarcinoma of the bladder

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Mitomycins
Mitomycin
Fluorouracil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014