Clinical trial NCT00010062: Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer
Official title: Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells left after surgery.

PURPOSE: Phase II trial to study the effectiveness of combining fluorouracil and radiation therapy in treating patients who have undergone surgery for pancreatic cancer.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Annemasse
country: France
facility: Clinique De Savoie
city: Bagnolet
country: France
facility: Clinique Floreal
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Caen
country: France
facility: Centre Regional Francois Baclesse
city: Cagne-sur-Mer
country: France
facility: Clinique Saint - Jean
city: Cagnes Sur Mer
country: France
facility: Polyclinique Saint Jean
city: Chartres
country: France
facility: Hopital Fontenoy
city: Clichy
country: France
facility: Hopital Beaujon
city: Colombes
country: France
facility: Hopital Louis Mourier
city: Dijon
country: France
facility: Hopital Drevon
city: Ermont
country: France
facility: Clinique Claude Bernard
city: Evreux
country: France
facility: Clinique Pasteur
city: Gien
country: France
facility: Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie
city: Grenoble
country: France
facility: CHR de Grenoble - La Tronche
city: La Rochelle
country: France
facility: Hopital Saint - Louis
city: Le Mans
country: France
facility: Centre Jean Bernard
city: Limoges
country: France
facility: Centre Hospital Regional Universitaire de Limoges
city: Paris
country: France
facility: Hopital Laennec
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: CHU Pitie-Salpetriere
city: Paris
country: France
facility: Hopital Tenon
city: Pontoise
country: France
facility: Clinique Ste - Marie
city: Quincy Sous Senart
country: France
facility: Hopital Claude Gallien
city: Reims
country: France
facility: Polyclinique De Courlancy
city: Saint Gregoire
country: France
facility: Clinique Saint Vincent
city: Sarcelles
country: France
facility: Centre du Rouget
city: Senlis
country: France
facility: C.H. Senlis
city: Suresnes
country: France
facility: Centre Medico-Chirurgical Foch
city: Toulouse
country: France
facility: Clinique Pasteur
city: Esch-sur-Alzette
country: Luxembourg
facility: Hopital de la Ville D'Esch-sur-Alzette
Study officials:
affiliation: CHU de Grenoble - Hopital de la Tronche
name: Jacques Balosso, MD, PhD
role: STUDY_CHAIR
References: