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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00003049 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: fluorouracil Drug: leucovorin calcium Procedure: conventional surgery Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized Trial of Extended Lymphadenectomy in the Management of Resectable Pancreatic Cancer\ |
| Estimated Enrollment: | 100 |
| Study Start Date: | May 1997 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
Greater than 5 years since prior malignancy except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations More Information
| Responsible Party: | Randall K. Pearson, M.D., Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003049 History of Changes |
| Other Study ID Numbers: | CDR0000065689, P30CA015083, 974301, G97-1302, 152-97 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 10, 2011 |
| Health Authority: | United States: Federal Government |
|
stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas |
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Fluorouracil Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents |
