CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Capecitabine +1 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/NCT00438256
NCT00438256Phase 2Completed

Phase I/II of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer

Massachusetts General Hospital·interventional·Posted Feb 22, 2007·Updated Jan 23, 2019

In Brief

A Phase 2 clinical trial evaluating Proton Beam Radiation and Capecitabine for Pancreatic Cancer. Completed, enrolled 50 participants across 2 sites.

Detailed Summary

A standard treatment for pancreatic cancer is radiation therapy plus chemotherapy after surgery. Radiation therapy and chemotherapy are commonly given for up to six weeks. Previous research has suggested that giving the radiation and chemotherapy for a shorter amount of time (accelerated schedule) before surgery may be better tolerated. In this research study, different schedules of proton radiation therapy will be used. Each schedule will give about the same total dose of radiation. However, the total dose will be spread out over different time periods and different numbers of sessions. The purpose is to find the shortest schedule of radiation therapy that can be given without unacceptable side effects. Proton beam radiation is being used because of its unique ability to deposit its energy directly in the tumor, resulting in less radiation to normal tissue. A new type of PET scan is also being studied to see if it can help predict the response to pre-surgery treatment.

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 22, 2007
Enrollment StartDec 1, 2007
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 10 yearsPosted 19.4 years ago

Interventions

Proton Beam Radiationprocedure

Given over different schedules and duration

Capecitabinedrug

Given orally starting on day one of radiation therapy for 2 weeks