Trial | NCT00002689  Report issue

Title

Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer
Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    urea fluorouracil ...

  • Study Participants

    48
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.
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.
Study Started
Sep 30
1995
Study Completion
Jun 30
2007
Last Update
Jul 18
2013
Estimate

Drug dexamethasone

Drug fluorouracil

Radiation brachytherapy

Radiation phosphorus P32

Radiation radiation therapy

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
No Results Posted