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

NCT ID: NCT00112697

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-06
• Study Completion Date: 2012-03-01

Brief 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.

Detailed 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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

docetaxel

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Arm 2

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Interventions

cisplatin

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel Ducreux, MD, PhD

Role: STUDY_CHAIR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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-Bénite, , France

Centre Rene Huguenin

Saint-Cloud, , France

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Institut Gustave Roussy

Villejuif, , France

Countries

France

References

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/0201 randomized phase II trial's pre-planned analysis and case report of a 5.5-year disease-free survival. Radiat Oncol. 2011 Sep 26;6:124. doi: 10.1186/1748-717X-6-124.

Reference Type: RESULT

PMID: 21943032 (View on PubMed)

Other Identifiers

FRE-FNCLCC-ACCORD-09/0201

Identifier Type: -

Identifier Source: secondary_id

EU-20511

Identifier Type: -

Identifier Source: secondary_id

CDR0000430095

Identifier Type: -

Identifier Source: org_study_id