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Phase 2
18 Years
Not Enrolling
Carcinoma, Transitional Cell

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Trial Information

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 intermediate biomarkers will be determined upon study entry after 8 weeks of
run-in/washout, and after 6 and 12 weeks of lycopene supplementation. It takes at least 20
weeks to complete the course.

Inclusion Criteria:

- 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

- 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 Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

changes of intermediate biomarker status after lycopene supplementation

Principal Investigator

Yeong-Shiau Pu, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

January 2006

Completion Date:

Related Keywords:

  • Carcinoma, Transitional Cell
  • Urothelial carcinoma
  • Lycopene
  • uremia
  • prevention
  • biomarker
  • progression
  • anti-oxidant
  • Carcinoma
  • Carcinoma, Transitional Cell