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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00112697
First received: June 2, 2005
Last updated: November 1, 2011
Last verified: December 2006

June 2, 2005
November 1, 2011
December 2002
Not Provided
Progression-free survival rate at 6 months [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00112697 on ClinicalTrials.gov Archive Site
  • Toxicity [ Designated as safety issue: Yes ]
  • Objective response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
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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
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: cisplatin
  • Drug: docetaxel
  • Drug: fluorouracil
  • Radiation: radiation therapy
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
Not Provided
Not Provided

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00112697
CDR0000430095, FRE-FNCLCC-ACCORD-09/0201, EU-20511
Not Provided
Not Provided
UNICANCER
Not Provided
Study Chair: Michel Ducreux, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
National Cancer Institute (NCI)
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP