Know Cancer

or
forgot password

Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer


OBJECTIVES:

- Determine the tolerance of adjuvant fluorouracil with concurrent radiotherapy in
patients with resected pancreatic adenocarcinoma.

- Determine survival without local relapse in these patients treated with this regimen.

- Determine overall survival of these patients treated with this regimen.

- Determine the effectiveness of this adjuvant therapy in these patients.

OUTLINE: This is a multicenter study.

Patients receive high-dose radiotherapy 5 days a week for 5 weeks. Patients also receive
low-dose radiotherapy 4 times a week during the last 2 weeks of the 5-week course of
treatment. Patients concurrently receive fluorouracil IV continuously for 5 weeks in the
absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed pancreatic adenocarcinoma

- Complete macroscopic resection of tumor within past 30 days

- No residual visceral or peritoneal metastasis

- Involvement of Vater's ampulla or extrahepatic bile duct allowed

- No vesicular or intrahepatic cholangiocarcinomas

PATIENT CHARACTERISTICS:

Age:

- 18 to 75

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Alkaline phosphatase less than 3 times normal

- Bilirubin less than 1.5 times normal

Renal:

- Creatinine less than 1.5 times normal

Cardiovascular:

- No serious cardiac failure

Pulmonary:

- No serious respiratory failure

Other:

- No other untreatable malignant tumors

- No serious psychological, familial, social, or geographical conditions that would
preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for pancreatic adenocarcinoma

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy for pancreatic adenocarcinoma

- No prior radiotherapy in an anatomically proximal region to treatment area

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jacques Balosso, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

CHU de Grenoble - Hopital de la Tronche

Authority:

United States: Federal Government

Study ID:

CDR0000068438

NCT ID:

NCT00010062

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location