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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
fluorouracil
leucovorin calcium
conventional surgery
radiation therapy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
December 20, 2016
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003049
Brief Title
Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas
Official Title
A Prospective, Randomized Trial of Extended Lymphadenectomy in the Management of Resectable Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
May 1997 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall K. Pearson, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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