Randomized Phase II Trial Evaluating [Radiotherapy-Docetaxel-5 Fluorouracil] Association Versus [Radiotherapy-Docetaxel-Cisplatin] Association in Non Resecables First Line of Chemotherapy in Metastatics Pancreas Cancers Patients

UNICANCER10 sites in 1 country71 target enrollmentOctober 6, 2003

ConditionsPancreatic Cancer

Interventionsdocetaxel fluorouracil radiation therapy cisplatin

Drugscisplatin docetaxel fluorouracil

Overview

Phase: Phase 2
Intervention: docetaxel
Conditions: Pancreatic Cancer
Sponsor: UNICANCER
Enrollment: 71
Locations: 10
Primary Endpoint: Progression-free survival rate at 6 months
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy, docetaxel, and fluorouracil are more effective than radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and fluorouracil to see how well they work as first-line therapy compared to radiation therapy, docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

Detailed Description

OBJECTIVES: Primary * Compare the 6-month progression-free survival rate in patients with unresectable metastatic adenocarcinoma of the pancreas treated with radiotherapy and docetaxel in combination with either fluorouracil or cisplatin as first-line therapy. Secondary * Compare the toxicity of these regimens in these patients. * Compare the objective response rate in patients treated with these regimens. * Compare overall survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo radiotherapy to the celiac area once daily 5 days a week for 6 weeks. Patients also receive docetaxel IV weekly and fluorouracil IV daily for 6 weeks. * Arm II: Patients undergo radiotherapy and receive docetaxel as in arm I. Patients also receive cisplatin IV weekly for 6 weeks. In both arms, patients experiencing disease progression after completion of chemoradiotherapy may receive additional courses of chemotherapy. PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 3 years.

Registry

clinicaltrials.gov

Start Date

October 6, 2003

End Date

March 1, 2012

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel