Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer

NCT ID: NCT00002689

Last Updated: 2013-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-09-30
• Study Completion Date: 2007-06-30

Brief Summary

RATIONALE: 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. Radiation therapy combined with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of brachytherapy followed by external-beam radiation therapy plus chemotherapy in treating patients who have pancreatic cancer that cannot be removed surgically.

Detailed Description

OBJECTIVES:

• Determine the response/remission rate, survival, and degree of local control from interstitial colloidal phosphorus P32 followed by external beam radiotherapy and chemotherapy in patients with unresectable pancreatic cancer.

OUTLINE: Patients are stratified according to prior therapy (yes vs no).

Patients receive dexamethasone intratumorally, then macroaggregated albumin and interstitial phosphorus P32 intratumorally. Most patients receive a second course of this brachytherapy.

Patients then proceed to chemoradiotherapy beginning 7-14 days after brachytherapy. Radiotherapy is administered 5 days a week for 6.4 weeks. Fluorouracil IV is administered every other day for 4 doses during weeks 1 and 2.

Patients are followed monthly for 1 year then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.

Conditions

Pancreatic Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

dexamethasone

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

brachytherapy

Intervention Type: RADIATION

phosphorus P32

Intervention Type: RADIATION

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically proven unresectable adenocarcinoma of the pancreas limited to the head, body, or tail of the pancreas

• Diameter no greater than 5 cm
• Volume no greater than 66 mL
• No ascites (with or without tumor cells)
• No endoscopically proven tumor penetration of duodenum or stomach

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Hematopoietic:

• WBC at least 3,000/mm3
• Platelet count at least 100,000/mm3
• Hemoglobin at least 9 g/dL (transfusion allowed)

Hepatic:

• No hepatic disease
• At least 50% uptake of technetium-sulfur colloid in normal liver if cirrhosis suspected
• No vascular occlusion of portal system

Renal:

• Creatinine no greater than 1.5 mg/dL
• BUN no greater than 25 mg/dL

Other:

• No Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
• Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• If prior chemotherapy, test dose of colloidal phosphorous P32 administered prior to attempted treatment

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to pancreas, liver, or upper gastrointestinal tract

Surgery:

• No complete surgical resection
• No splenectomy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Molecular Medicine

OTHER

Sponsor Role: lead

Principal Investigators

Stanley E. Order, MD, ScD, FACR

Role: STUDY_CHAIR

Center for Molecular Medicine

Locations

Northside Hospital Cancer Center

Atlanta, Georgia, United States

Center for Molecular Medicine

Garden City, New York, United States

Countries

United States

Other Identifiers

CDR0000064415

Identifier Type: REGISTRY

Identifier Source: secondary_id

CH/UMC-95079

Identifier Type: -

Identifier Source: secondary_id

NCI-V95-0760

Identifier Type: -

Identifier Source: secondary_id

CMM-95079

Identifier Type: -

Identifier Source: org_study_id