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| Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003623 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Dietary Supplement: multivitamin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized |
| Official Title: | Megadose Vitamins as Chemoprevention of Transitional Cell Carcinoma of the Bladder |
| Estimated Enrollment: | 360 |
| Study Start Date: | October 1999 |
OBJECTIVES: I. Determine whether high dose multivitamins have chemopreventive efficacy beyond standard therapy in reducing the risk of recurrence in patients with resected stage 0 and I (Ta, T1, and Tis) transitional cell carcinoma of the bladder.
OUTLINE: This is a randomized, double blind study. Patients are randomized to receive multivitamins or placebo orally once daily for 3 years. Patients are followed every 3 months for 2 years, then every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 360 patients (180/arm) will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Arizona | |
| CCOP - Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, Illinois | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| Siouxland Hematology-Oncology | |
| Sioux City, Iowa, United States, 51101-1733 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Michigan | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| CentraCare Clinic | |
| Saint Cloud, Minnesota, United States, 56303 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, North Dakota | |
| Altru Health Systems | |
| Grand Forks, North Dakota, United States, 58201 | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| Medcenter One Health System | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Ohio | |
| CCOP - Toledo Community Hospital Oncology Program | |
| Toledo, Ohio, United States, 43623-3456 | |
| United States, South Dakota | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57105-1080 | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57709 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Study Chair: | Michael L. Blute, MD | Mayo Clinic |
More Information
| Study ID Numbers: | CDR0000066702, NCCTG-979252, NCI-P98-0138 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003623 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent bladder cancer |
|
Urinary Tract Neoplasm Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms |
Recurrence Carcinoma Urologic Diseases Vitamins Bladder Neoplasm Neoplasms, Glandular and Epithelial Transitional Cell Carcinoma |
|
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Urologic Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms |
Urogenital Neoplasms Urologic Neoplasms Carcinoma, Transitional Cell Neoplasms, Glandular and Epithelial Carcinoma |
