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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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
cisplatin
docetaxel
fluorouracil
radiation therapy
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Paul Papin
  • Centre Oscar Lambret
  • Polyclinique des Quatre Pavillons
  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Centre Regional Rene Gauducheau
  • Centre Hospitalier Lyon Sud
  • Centre Rene Huguenin
  • Centre Alexis Vautrin
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival rate at 6 months

Secondary Outcome Measures

Toxicity
Objective response rate
Overall survival

Full Information

First Posted
June 2, 2005
Last Updated
February 15, 2021
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT00112697
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 6, 2003 (Actual)
Primary Completion Date
August 1, 2008 (Actual)
Study Completion Date
March 1, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Progression-free survival rate at 6 months
Secondary Outcome Measure Information:
Title
Toxicity
Title
Objective response rate
Title
Overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Ducreux, MD, PhD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49036
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Polyclinique des Quatre Pavillons
City
Lormont
ZIP/Postal Code
33310
Country
France
Facility Name
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Regional Rene Gauducheau
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21943032
Citation
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.
Results Reference
result

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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

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