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
18 Years
75 Years
Both
Pancreatic Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival rate at 6 months
Safety Issue:
No
Principal Investigator
Michel Ducreux, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Gustave Roussy, Cancer Campus, Grand Paris
Authority:
United States: Federal Government
Study ID:
CDR0000430095
NCT ID:
NCT00112697
Start Date:
December 2002
Completion Date:
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- stage IV pancreatic cancer
- Pancreatic Neoplasms
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