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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Loco-regional disease free survival at 2 years

Safety Issue:

No

Principal Investigator

Nicholas D. James, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000068921

NCT ID:

NCT00024349

Start Date:

June 2001

Completion Date:

Related Keywords:

  • Bladder Cancer
  • stage II bladder cancer
  • stage III bladder cancer
  • transitional cell carcinoma of the bladder
  • squamous cell carcinoma of the bladder
  • adenocarcinoma of the bladder
  • Urinary Bladder Neoplasms

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