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Completed

NCT Number: NCT00002689

Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northside Hospital Cancer Center, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Fluorouracil

Drug

Brachytherapy

Radiation

phosphorus P32

Radiation

radiation therapy

Radiation

Primary outcomes

  1. Response rate

  2. Duration of remission

  3. Survival

Secondary outcomes

  1. Patterns of failure

Sponsors and collaborators

Lead sponsor

Center for Molecular Medicine

Other

Registry information

Official study title

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

Important dates

Study start
1995
Study completion
2007
First posted
Jan 27, 2003
Registry last updated
Jul 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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