Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
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:	Treatment, Randomized, Active Control
Official Title:	A Prospective, Randomized Trial of Extended Lymphadenectomy in the Management of Resectable Pancreatic Cancer\

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer Surgery

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	100
Study Start Date:	May 1997

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003049

Locations

United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:

Randall K. Pearson, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000065689, MAYO-974301, NCI-G97-1302
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003049 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:

Antimetabolites
Vitamin B Complex
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Leucovorin

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Vitamins
Therapeutic Uses
Fluorouracil
Pancreatic Diseases
Micronutrients
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010