Surgery Followed By Radiation Therapy And Chemotherapy In Treating Patients With Cancer Of The Pancreas

Study Overview

Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas

RATIONALE: Surgery to remove the pancreas, some of the small intestine, and lymph nodes may be more effective treatment for cancer of the pancreas than surgery to remove the pancreas and some of the small intestine alone. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery, radiation therapy, and chemotherapy may be an effective treatment for cancer of the pancreas. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the pancreas and a portion of the small intestine with or without removing lymph nodes, followed by radiation therapy and chemotherapy, in treating patients with cancer of the pancreas.

OBJECTIVES: * Assess the overall survival of patients with resectable ductal pancreatic adenocarcinoma undergoing extended versus standard pancreatoduodenectomy. OUTLINE: Patients are randomized to undergo standard pancreatoduodenectomy (PD) or PD with extended lymph node resection after an exploratory laparotomy. Patients receive adjuvant chemoradiation therapy 4-6 weeks after surgery, if no metastases are evident. Radiation therapy is given every week for 5 weeks. Fluorouracil/leucovorin calcium is administered by rapid IV push daily within 2 hours of radiation on days 1-4 of week 1 and days 29-31 of week 5. Patients are followed every 4 months for the first year, then every 6 months for the next 2 years. PROJECTED ACCRUAL: 50 patients will be accrued per group for a total of 100 patients.

Pancreatic Cancer

DRUG: fluorouracil
DRUG: leucovorin calcium
PROCEDURE: conventional surgery
RADIATION: radiation therapy

CDR0000065689
P30CA015083 (U.S. NIH Grant/Contract)
974301 (OTHER Identifier) (OTHER: Mayo Clinic Cancer Center)
G97-1302 (OTHER Identifier) (OTHER: NCI Protocol)
152-97 (OTHER Identifier) (OTHER: Mayo Clinic IRB)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 1999-11-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-12-20
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-12-22
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2011-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically proven adenocarcinoma of the exocrine pancreas excluding periampullary cancer
Resectable malignancy must be located in a region that can be encompassed by a radiation port of 20 x 20 cm
No evidence of extranodal metastatic disease

18 and over

ECOG 0-2

Not specified

WBC at least 3500/mm^3
Platelet count at least 100,000/mm^3

Not specified

Bilateral renal function as demonstrated by excretory urogram (IVP) or abdominal CT scan with contrast OR
Greater than 2/3 of one functioning kidney must be shielded during radiation therapy

Must have adequate oral nutrition (greater than 1200 calories daily)
Greater than 5 years since prior malignancy except:

Squamous cell skin cancer
Basal cell skin cancer
In situ cervical cancer
Not pregnant or lactating
Patients of reproductive potential must use effective birth control
No cystic neoplasms of the pancreas
No islet cell, periampullary or cholangiocarcinoma
No Federal Medical Center inmates

Not specified

No prior chemotherapy for this disease

Not specified

No prior radiation therapy for this disease
No prior radiation therapy to the abdomen

Celiotomy and standardized exploration for resectability required

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Randall K. Pearson, MD, Mayo Clinic

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record