Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer

Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002689

Enrollment

Registered

2003-01-27

Start date

1995-09-30

Completion date

2007-06-30

Last updated

2013-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

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

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.

Interventions

DRUGdexamethasone

DRUGfluorouracil

RADIATIONbrachytherapy

RADIATIONphosphorus P32

RADIATIONradiation therapy

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Response rate	—
Duration of remission	—
Survival	—

Secondary

Measure	Time frame
Patterns of failure	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026