CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Gemcitabine +1 moredrug
Likely dose
Gemcitabine 1000mg/m2from 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/NCT00593866
NCT00593866Phase 2Completed

A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer

University of Michigan Rogel Cancer Center·interventional·Posted Jan 15, 2008·Updated Sep 11, 2015

In Brief

A Phase 2 clinical trial evaluating INTENSITY MODULATED RADIOTHERAPY and Gemcitabine for Pancreatic Cancer. Completed, enrolled 50 participants across 2 sites.

Detailed Summary

This is a research study for pancreatic cancer. One way of improving the results of current standard treatments is to try new approaches. This study will examine the use of a more advanced radiation therapy technique, called intensity modulated radiation therapy (IMRT), with chemotherapy. All subjects on this study will be treated with gemcitabine. This chemotherapy agent has been used for patients with pancreatic cancer. The researchers have already done studies using radiation therapy and gemcitabine. They want to build on the information they have from this previous research. The researchers want to find the best dose of IMRT that can be given at the same time that patients are receiving gemcitabine. To do this, they will vary the total dose of radiation received by patients on this study based on the information they have available from previously treated patients. The goal of the research is to identify the highest dose of IMRT that can be given at the same time as the chemotherapy without causing severe side effects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 15, 2008
Enrollment StartJun 1, 2006
Primary CompletionMay 1, 2012
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 18.5 years ago

Interventions

INTENSITY MODULATED RADIOTHERAPYradiation

Five fractions weekly, fraction size determined by dose level

Gemcitabinedrug

1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment