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Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy

NCT00766636 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2016-05-19

Study results available
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Summary

Primary Objective:

To assess margin positive resection rate (R1 resection rate; defined as "tumor within 2 mm of surgical margin on final pathology report") in patients treated with preoperative chemotherapy (gemcitabine and erlotinib) with or without external-beam radiation therapy followed by pancreaticoduodenectomy for adenocarcinoma of the pancreatic head.

Secondary Objectives:

* To assess disease free survival
* To assess overall survival
* To assess patterns of local and distant failure

Conditions

Interventions

DRUG

Gemcitabine

Arm A: 1000 mg/M\^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Arm B: 400 mg/M\^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day.

RADIATION

Radiation Therapy

1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy.

DRUG

Erlotinib

100 mg daily by mouth on days 1-42.

PROCEDURE

Surgery

Surgical removal of the pancreas and duodenum

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jason B. Fleming, MD · UT MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2012-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00766636 on ClinicalTrials.gov