CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
Placebo +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00666562
NCT00666562Phase 2Completed
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A Phase II Randomized, Placebo-Controlled Trial of Polyphenon E to Evaluate Bladder Tissue Levels of EGCG

National Cancer Institute (NCI)·interventional·Posted Apr 25, 2008·Updated Nov 17, 2017

In Brief

A Phase 2 clinical trial evaluating Defined Green Tea Catechin Extract, Laboratory Biomarker Analysis, and 3 other interventions for Stage I Bladder Cancer and 2 related conditions. Completed, enrolled 31 participants across 6 sites.

Detailed Summary

Green tea extract contains ingredients that may slow the growth of certain cancers. It is not yet known whether green tea extract is more effective than a placebo when given before surgery in treating patients with bladder. This randomized phase II trial is studying green tea extract to see how well it works compared to a placebo when given before surgery in treating patients with nonmetastatic bladder cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage I Bladder Cancer, Stage II Bladder Cancer, Stage III Bladder Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 25, 2008
Enrollment StartJul 2, 2008
Primary CompletionApr 26, 2012
Study CompletionJun 9, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 18.2 years ago

Interventions

Defined Green Tea Catechin Extractdietary

Given orally

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies

Placebodrug

Given orally

Therapeutic Conventional Surgeryprocedure

Undergo surgery