Status:
WITHDRAWN
Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Carcinoma, Transitional Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary Objective: To study if lycopene can improve the biomarker status of urothelial cells in patients with uremia-associated urothelial carcinoma. Secondary Objective: To evaluate the general safe...
Detailed Description
This is a renal function-stratified phase II chemoprevention trial. After 8 weeks of a run-in and washout period, participants will take lycopene, 30 mg per day for 12 weeks. The expression of interme...
Eligibility Criteria
Inclusion
- Patients have pathologically-proven urothelial carcinoma (UC) with a clinical stage \<= T3N0M0
- Patients have no visible or identifiable residual UC after treatment with a life expectancy of \> 6 months
- Patients have remaining urothelium at risk of recurrence (transplanted renal unit excluded)
- No other active malignancy. Patients who have other primary malignancies should be treated successfully prior to the study entry and should be in a cure or remission state for at least one year.
- Patients are able to take lycopene capsules orally.
- Patients who sign and give informed consents and are willing to conform to the scheduled sampling of the blood, urine and/or tissue
Exclusion
- Patients who have clinical stage \> T3N0M0 or metastatic disease
- Positive urine cytology. Patients who have positive cytology should be subjected to a serial diagnostic workup which may include renal echo, cystoscopy and ureterorenoscopy, and image studies (intravenous urography, computed tomography, magnetic resonance urography, retrograde or antegrade pyelography). If no recurrent or residual tumors are found, patients are still eligible for the study.
- Patients who have ever received systemic chemotherapy within 12 months
- Patients who have gastrointestinal malabsorption regardless of the etiology
- Have known allergic reaction to tomato or lycopene
- Patients who are participating or will participate in other clinical trials
- Patients who have active urinary tract infection can not be accrued until infection is effectively controlled
- Patient's age is less than 18 years
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00172367
Start Date
January 1 2006
Last Update
September 26 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Taiwan University Hospital
Taipei, Taiwan