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Perioperative Therapy for Resectable Pancreatic Cancer

NCT00609336 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-07-13

Study results available
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Summary

This phase II trial studies how well giving combination chemotherapy together with intensity-modulated radiation therapy (IMRT) and surgery works in treating patients with localized pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as IMRT, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug (combination chemotherapy) together with intensity-modulated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.

Conditions

  • Adenocarcinoma of the Pancreas
  • Stage IA Pancreatic Cancer
  • Stage IB Pancreatic Cancer
  • Stage IIA Pancreatic Cancer
  • Stage IIB Pancreatic Cancer

Interventions

DRUG

gemcitabine hydrochloride

Given IV

DRUG

docetaxel

Given IV

DRUG

capecitabine

Given PO

RADIATION

intensity-modulated radiation therapy

Undergo IMRT

DRUG

oxaliplatin

Given IV

PROCEDURE

pancreatic surgical procedure

Undergo pancreaticoduodenectomy

PROCEDURE

therapeutic conventional surgery

Undergo therapeutic conventional surgery

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

Principal Investigators

  • Andrew Coveler · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2014-11-30
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00609336 on ClinicalTrials.gov