Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over NCI MAYO-974301 NCI-G97-1302, NCT00003049

Objectives

1. Assess the overall survival of patients with resectable ductal pancreatic adenocarcinoma undergoing extended versus standard pancreatoduodenectomy.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

50 patients will be accrued per group for a total of 100 patients.

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.

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

Randall Pearson, MD, Protocol chair		Ph: 507-284-2478

Registry Information
Official Title		A Prospective, Randomized Trial of Extended Lymphadenectomy in the Management of Resectable Pancreatic Cancer\
Trial Start Date		1997-05-22
Registered in ClinicalTrials.gov		NCT00003049
Date Submitted to PDQ		1997-08-18
Information Last Verified		2003-09-24
NCI Grant/Contract Number		P30-CA15083

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