Radiotherapy With Chemotherapy as Neoadjuvant Therapy of Resectable and Borderline Resectable Pancreas Cancer

Phase 2

• Conditions: Pancreatic Cancer
• Interventions: Drug: Capecitabine; Radiation: Standard Dose Acclerated Fraction Radiotherapy

• Registration Number: NCT01333332
• Lead Sponsor: University of Virginia

Brief Summary

The purpose of this study is to determine safety and to obtain preliminary estimates of the rate of major pathologic response of neoadjuvant accelerated fraction, standard dose radiation given with chemotherapy in patients with locally advanced pancreas cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-03-04
• Status Verified: 2011-04
• Study First Submitted QC: 2011-04-08
• Last Update Submitted: 2011-04-08
• Study First Posted: 2011-04-11
• Last Update Posted: 2011-04-11
• Primary Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capecitabine, Radiation	Standard Dose Acclerated Fraction Radiotherapy	-
Capecitabine, Radiation	Capecitabine	-

Primary Outcome Measures

Name	Time	Method
To determine the safety of neoadjuvant accelerated fraction standard dose radiotherapy to 50 Gy with concomitant capecitabine in patients with resectable and borderline resectable pancreas cancer.	2 years

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States