CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
Gemcitabine +2 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/NCT01146054
NCT01146054Phase 2Completed

Phase II Multi-Institutional Study to Evaluate the Efficacy of Gemcitabine and Fractionated Stereotactic Radiotherapy for Unresectable Pancreatic Adenocarcinoma

Stanford University·interventional·Posted Jun 17, 2010·Updated Dec 19, 2017

In Brief

A Phase 2 clinical trial evaluating CyberKnife based stereotactic radiotherapy, Gemcitabine, and 1 other intervention for Pancreatic Cancer. Completed, enrolled 59 participants across 3 sites.

Detailed Summary

This multi-institutional trial aims to evaluate the potential benefit and side effects of adding fractionated stereotactic body radiotherapy/surgery (SBRT) before and after chemotherapy with gemcitabine for locally advanced pancreatic cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 17, 2010
Enrollment StartOct 1, 2009
Primary CompletionOct 1, 2013
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 16.0 years ago

Interventions

CyberKnife based stereotactic radiotherapydevice

1. Initial orthogonal images will be obtained to confirm location of fiducial seeds. 2. Synchrony respiratory tracking system must be used to correct for respiratory associated tumor motion. This system utilizes a series of optical diodes placed upon the patient's chest wall. While the orthogonal images are obtained, the computer generates a model correlating the position of the chest wall with the position of the internal fiducials. This model is continuously updated during treatment to correct for subtle changes in tumor location. 3. Quality assurance will be performed as per standard practice at each participating institution.

Gemcitabinedrug

Treatment calculated per the needs of each patient and given at the instruction of the investigator; iv (intravenous).

Fludeoxyglucose (18F) (FDG)drug

FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv