CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Gemcitabinedrug
Likely dose
Gemcitabine 1250 mgfrom 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/NCT00390182
NCT00390182Phase 2Completed
CompareCT.gov

GCC 0319: Low Dose Upper Abdominal Radiation Therapy (LD-UART) + Gemcitabine in Patients With Advanced, Unresectable Pancreatic Cancer (PC)

University of Maryland, Baltimore·interventional·Posted Oct 19, 2006·Updated Mar 18, 2020

In Brief

A Phase 2 clinical trial evaluating Gemcitabine for Gastrointestinal Neoplasms and Ovarian Neoplasms. Completed, enrolled 38 participants across 2 sites in 2 countries.

Detailed Summary

The purposes of this study are: 1. To assess the maximum tolerated dose of low-dose UART(Upper Abdominal Radiation Therapy ) or WART(Whole Abdominal Radiation Therapy) given in combination with standard fixed dose-rate Gemcitabine in patients with advanced gastrointestinal (GI) or ovarian tumors (Phase I). 2. To assess response rate and survival in advanced upper GI tumors following completion of therapy (Phase II).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Neoplasms, Ovarian Neoplasms
CountriesCanada, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 19, 2006
Enrollment StartOct 1, 2003
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 19.7 years ago

Interventions

Gemcitabinedrug

Gemcitabine will be given at 1250 mg per meter squared over 2 hours days 1 and 8 of a 21 day cycle for a total of 4 cycles. Radiation:External Radiation Therapy The total dose would be 19.2 Gy divided over 32 fractions twice a day, on day 1 and day 8 after chemotherapy. \*\*Radiation is the experimental part of the study.