Preop Chemoradiation Resectable Pancreas

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00336648
Phase
PHASE2
Status
Completed

Conditions

  • Pancreatic Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Avastin (Bevacizumab) — DRUG
    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.
  • Gemcitabine — DRUG
    400 mg/m2 IV once a week on Days 1, 2, 8,15, 22, 29, 36 +/-2 days (Saturdays)
  • Radiation Therapy — PROCEDURE
    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)

Study Details

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

Key Dates

First listed
Jun 14, 2006
Start date
Jun 30, 2006
Status verified
Jul 2012
Primary completion
Sep 30, 2007
Completion
Jul 31, 2008

Study Design

Enrollment
11 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine + Avastin + Surgery
    Gemcitabine plus Avastin-based chemoradiation followed by pancreaticoduodenectomy

Primary Outcome Measure

Number of Patients with Resection [ Time Frame: 8 weeks (+/- 2 days) after the completion of chemoradiation ]

Locations (1)

FacilityCityStateZIPSite coordinators
U.T. M.D. Anderson Cancer CenterHoustonTexas77030-

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