Radiation Therapy and Docetaxel With Either Fluorouracil or Cisplatin as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

Pancreatic Cancer Clinical Trial

Official title:

Randomized Phase II Trial Evaluating [Radiotherapy-Docetaxel-5 Fluorouracil] Association Versus [Radiotherapy-Docetaxel-Cisplatin] Association in Non Resecables First Line of Chemotherapy in Metastatics Pancreas Cancers Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00112697
• Other study ID #: CDR0000430095
• Secondary ID: FRE-FNCLCC-ACCOR
• Status: Completed
• Phase: Phase 2
• Start date: October 6, 2003
• Est. completion date: March 1, 2012

Study information

• Verified date: February 2021
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy, docetaxel, and fluorouracil are more effective than radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and fluorouracil to see how well they work as first-line therapy compared to radiation therapy, docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

Description:

OBJECTIVES:

Primary

• Compare the 6-month progression-free survival rate in patients with unresectable metastatic adenocarcinoma of the pancreas treated with radiotherapy and docetaxel in combination with either fluorouracil or cisplatin as first-line therapy.

Secondary

• Compare the toxicity of these regimens in these patients.

• Compare the objective response rate in patients treated with these regimens.

• Compare overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo radiotherapy to the celiac area once daily 5 days a week for 6 weeks. Patients also receive docetaxel IV weekly and fluorouracil IV daily for 6 weeks.

• Arm II: Patients undergo radiotherapy and receive docetaxel as in arm I. Patients also receive cisplatin IV weekly for 6 weeks.

In both arms, patients experiencing disease progression after completion of chemoradiotherapy may receive additional courses of chemotherapy.

PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 1, 2012
• Est. primary completion date: August 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

• No other pancreatic tumor type, including either of the following:

• Neuroendocrine tumor

• Ampulla of Vater carcinoma

• Metastatic disease

• Measurable or evaluable disease

• Unresectable disease, defined as either of the following:

• Failed prior attempt of surgical resection by laparotomy

• Surgical resection contraindicated by radiographic criteria (e.g., arterial vascular invasion)

• No cerebral metastases

PATIENT CHARACTERISTICS:

Age

• 18 to 75

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count = 1,500/mm^3

• Platelet count = 100,000/mm^3

Hepatic

• Bilirubin < 1.5 times upper limit of normal

• No hepatic disturbance

Renal

• Creatinine < 120 mmol/L

Cardiovascular

• No untreated cardiac or coronary insufficiency

• No uncontrolled symptomatic arrhythmia

• No uncontrolled angina

Pulmonary

• No uncontrolled respiratory insufficiency

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix

• No peripheral neuropathy = grade 2

• No ongoing active infection

• No other serious uncontrolled medical disorder that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to the celiac or pancreatic area

Surgery

• See Disease Characteristics

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• cisplatin

• docetaxel

• fluorouracil

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Centre Oscar Lambret	Lille
France	Polyclinique des Quatre Pavillons	Lormont
France	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	Marseille
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	Centre Regional Rene Gauducheau	Nantes-Saint Herblain
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	Centre Rene Huguenin	Saint Cloud
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

References & Publications (1)

Oberic L, Viret F, Baey C, Ychou M, Bennouna J, Adenis A, Peiffert D, Mornex F, Pignon JP, Celier P, Berille J, Ducreux M. Docetaxel- and 5-FU-concurrent radiotherapy in patients presenting unresectable locally advanced pancreatic cancer: a FNCLCC-ACCORD/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival rate at 6 months
Secondary	Toxicity
Secondary	Objective response rate
Secondary	Overall survival