Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer

NCT00002689 | Completed Phase 2

• 4 other identifiers: CMM-95079CDR0000064415CH/UMC-95079NCI-V95-0760
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Response rate

• Duration of remission

• Survival

Secondary Outcomes (1)

• Patterns of failure

Interventions

dexamethasone DRUG

fluorouracil DRUG

brachytherapy RADIATION

phosphorus P32 RADIATION

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Center for Molecular Medicine: lead

Study Sites (2)

Northside Hospital Cancer Center

Atlanta, Georgia, 30342-1611, United States

Location

Center for Molecular Medicine

Garden City, New York, 11530, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Dexamethasone; Fluorouracil; Brachytherapy; Phosphorus-32; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Stanley E. Order, MD, ScD, FACR

  Center for Molecular Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: September 1, 1995
• Study Completion: June 1, 2007
• Last Updated: July 18, 2013

Record last verified: 2007-06

Locations

US (2)