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Gemcitabine and Oxaliplatin Followed By Radiation Therapy, Fluorouracil, and Oxaliplatin in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00275119
Recruitment Status : Unknown
Verified January 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 11, 2006
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin followed by radiation therapy, fluorouracil, and oxaliplatin works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: oxaliplatin Radiation: radiation therapy Phase 2

Detailed Description:



  • Compare progression-free survival of patients with locally advanced, nonresectable adenocarcinoma of the pancreas treated with gemcitabine hydrochloride and oxaliplatin followed by concurrent radiotherapy, fluorouracil, and oxaliplatin.


  • Determine the tolerability of this regimen, in both the short- and long-term, in these patients.
  • Determine recurrence-free survival, overall survival, and response rate in patients treated with this regimen.
  • Determine the quality of life of patients treated with this regimen.
  • Determine the clinical benefits of this regimen in these patients.
  • Determine locoregional and metastatic progression-free survival of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

  • Chemotherapy: Patients receive gemcitabine hydrochloride over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are restaged at day 15-21 of the fourth course of chemotherapy. Patients with nonmetastatic disease proceed to chemoradiotherapy.
  • Chemoradiotherapy: Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive fluorouracil IV continuously in weeks 1-5 and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29 in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at restaging, and at day 28 after completion of chemoradiotherapy.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Protocole de Phase II: Etude de Faisabilite de L'Oxaliplatine en Association Chimio-Radiotherapie Concomitante Dans le Traitement Des Cancers du Pancreas Localement Avances Non Resecables
Study Start Date : November 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Progression-free survival

Secondary Outcome Measures :
  1. Tolerability
  2. Recurrence-free survival
  3. Overall survival
  4. Response rate
  5. Quality of life
  6. Clinical benefits
  7. Locoregional and metastatic progression-free survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the pancreas

    • Locally advanced, nonresectable disease
    • Residual disease after surgical resection (R1, R2) OR recurrent disease after radical surgery
  • No visceral or peritoneal metastases
  • No adenocarcinoma of the bile ducts or the ampulla of Vater


  • ECOG performance status 0-2
  • Stable or controlled pain with analgesics
  • Not pregnant or nursing
  • Neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 1.5 times normal OR < 3 mg/dL
  • Creatinine clearance ≥ 40 mL/min
  • Bilirubin ≤ 1.5 times normal
  • Alkaline phosphatase < 5 times normal
  • No medical condition that would preclude study treatment
  • No active infection
  • Negative pregnancy test
  • No serious cardiac or respiratory disease
  • No uncontrolled or persistent hypercalcemia
  • No pre-existing neuropathy
  • No biliary or gastro-duodenal obstruction
  • No other malignancy except nonmelanomatous skin cancer, prostate cancer, or carcinoma in situ of the cervix or bladder
  • No familial, social, geographical, or psychological condition that would preclude study compliance


  • See Disease Characteristics
  • No prior abdominal radiotherapy (encompassing the liver, pancreas, or spleen)
  • At least 2 months since prior radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00275119

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Institut Sainte Catherine
Avignon, France, 84082
Hopital Saint Andre
Bordeaux, France, 33075
Clinique Tivoli
Bordeaux, France, F-33000
Hopital Drevon
Dijon, France, 21000
CHU de Grenoble - Hopital de la Tronche
Grenoble, France, F-38043
Hopital Saint - Louis
La Rochelle, France, 17000
Clinique Victor Hugo
Le Mans, France, F-72000
Clinique Saint Jean
Lyon, France, 69008
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13009
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
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Study Chair: Laurence Moureau-Zabotto, MD Institut Paoli-Calmettes

Publications of Results:
Layout table for additonal information Identifier: NCT00275119    
Other Study ID Numbers: CDR0000454568
First Posted: January 11, 2006    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: January 2006
Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs