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

NCT00003049 | Completed Phase 3 DMC

• 5 other identifiers: CDR0000065689P30CA015083974301G97-1302152-97
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

stage I pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer; adenocarcinoma of the pancreas

Interventions

fluorouracil DRUG

leucovorin calcium DRUG

conventional surgery PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Not specified Renal: * 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 Other: * 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 PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for this disease Endocrine therapy: * Not specified Radiotherapy: * No prior radiation therapy for this disease * No prior radiation therapy to the abdomen Surgery: * Celiotomy and standardized exploration for resectability required

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Fluorouracil; Leucovorin; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Therapeutics

Study Officials

• Randall K. Pearson, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: May 1, 1997
• Primary Completion: August 1, 2005
• Study Completion: July 1, 2007
• Last Updated: December 22, 2016

Record last verified: 2011-05

Locations

US (1)