Bladder Cancer Clinical Trial
Official title:
Megadose Vitamins as Chemoprevention of Transitional Cell Carcinoma of the Bladder
Verified date | July 2016 |
Source | Alliance for Clinical Trials in Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. The use of high-dose multivitamins may be an effective
way to prevent the recurrence of early stage bladder cancer. It is not yet known whether
high-dose vitamins are more effective than no further therapy in decreasing the risk of
early-stage bladder cancer.
PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of high-dose
multivitamins with a placebo in preventing the recurrence of cancer in patients with early
stage bladder cancer.
Status | Completed |
Enrollment | 21 |
Est. completion date | March 2003 |
Est. primary completion date | March 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: Histologically confirmed stage 0 and I (Ta, T1 or Tis) resected
transitional cell carcinoma of the bladder No advanced disease or muscle invasion No
history of transitional cell carcinoma of the prostate PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Greater than 3 years Hematopoietic: WBC at least 3500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN SGOT no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception At least 5 years since prior malignancy except nonmetastatic squamous cell or basal cell carcinoma of the skin No history of drug interactions which could affect therapy No immunodeficiency PRIOR CONCURRENT THERAPY: Biologic therapy: Prior intravesical BCG required (if T1 or Tis pathology and negative cytology PAB) Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the pelvis Surgery: Not specified Other: Intravesical therapy within 30 days allowed At least 30 days since greater than 2 multivitamins daily |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | Allan Blair Cancer Centre | Regina | Saskatchewan |
United States | CCOP - Ann Arbor Regional | Ann Arbor | Michigan |
United States | Medcenter One Health System | Bismarck | North Dakota |
United States | CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa |
United States | CCOP - Iowa Oncology Research Association | Des Moines | Iowa |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | CCOP - Merit Care Hospital | Fargo | North Dakota |
United States | Altru Health Systems | Grand Forks | North Dakota |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | CentraCare Clinic | Saint Cloud | Minnesota |
United States | CCOP - Scottsdale Oncology Program | Scottsdale | Arizona |
United States | Siouxland Hematology-Oncology | Sioux City | Iowa |
United States | CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota |
United States | CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
United States | CCOP - Wichita | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevention of reoccurence of early stage bladder cancer | Up to 5 years | No |
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