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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: fluorouracil
* Drug: leucovorin calcium
* Procedure: conventional surgery
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluorouracil|nan|
|Drug: leucovorin calcium|nan|
|Procedure: conventional surgery|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas