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Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dexamethasone
fluorouracil
brachytherapy
phosphorus P32
radiation therapy
Sponsored by
Center for Molecular Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northside Hospital Cancer Center
  • Center for Molecular Medicine

Outcomes

Primary Outcome Measures

Response rate
Duration of remission
Survival

Secondary Outcome Measures

Patterns of failure

Full Information

First Posted
November 1, 1999
Last Updated
July 17, 2013
Sponsor
Center for Molecular Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00002689
Brief Title
Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer
Official Title
Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
September 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Center for Molecular Medicine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Type
Radiation
Intervention Name(s)
phosphorus P32
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Response rate
Title
Duration of remission
Title
Survival
Secondary Outcome Measure Information:
Title
Patterns of failure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley E. Order, MD, ScD, FACR
Organizational Affiliation
Center for Molecular Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Northside Hospital Cancer Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1611
Country
United States
Facility Name
Center for Molecular Medicine
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States

12. IPD Sharing Statement

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Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer

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