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

A Prospective, Randomized Trial of Extended Lymphadenectomy in the Management of Resectable Pancreatic Cancer

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: fluorouracil; Drug: leucovorin calcium; Radiation: radiation therapy; Procedure: conventional surgery

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Randall K. Pearson, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: May 1, 1997
• Primary Completion (Actual): August 1, 2005
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): December 22, 2016
• Last Update Submitted That Met QC Criteria: December 20, 2016
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: adenocarcinoma of the pancreas; stage III pancreatic cancer; stage I pancreatic cancer; stage II pancreatic cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Micronutrients; Vitamins; Calcium-Regulating Hormones and Agents; Antidotes; Vitamin B Complex; Fluorouracil; Leucovorin; Calcium; Levoleucovorin
• Other Study ID Numbers: CDR0000065689; P30CA015083 (U.S. NIH Grant/Contract); 974301 (Other Identifier: Mayo Clinic Cancer Center); G97-1302 (Other Identifier: NCI Protocol); 152-97 (Other Identifier: Mayo Clinic IRB)