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Preop Chemoradiation Resectable Pancreas

NCT00336648 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2012-07-30

No results posted yet for this study

Summary

Primary Objective:

1\. To assess resectability rate in patients undergoing gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy for adenocarcinoma of the pancreas.

Secondary Objectives:

1. To assess disease free survival and overall survival
2. To assess margin resection rate (R0 vs. R1) in these patients
3. To assess patterns of failure

Conditions

  • Pancreatic Neoplasms

Interventions

DRUG

Avastin (Bevacizumab)

10mg/kg by vein (IV) on Days 1, 2, 15 and 29 the adjuvant therapy every two weeks starting approximately 6 weeks after surgery for three months.

DRUG

Gemcitabine

400 mg/m2 IV once a week on Days 1, 2, 8,15, 22, 29, 36 +/-2 days (Saturdays)

PROCEDURE

Radiation Therapy

Day 3 +/-2 days (Monday) Start Radiation therapy, Mon -Fri x 28 days; 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions)

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Douglas Evans, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2007-09-30
Completion
2008-07-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00336648 on ClinicalTrials.gov