Clinical trial NCT00003049: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Randall K. Pearson, MD
role: STUDY_CHAIR
References: