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Study Comparing Radiochemotherapy With Folfox 4 Regimen or 5FU-Cisplatin in Patients With Inoperable Esophageal Cancer

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: NCT00160030
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : December 7, 2009
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Brief Summary:

The primary objectives of this study are to assess the feasibility (completion of full treatment) in both arms and to assess endoscopic complete response rate in both arms.

The secondary objective of this study is to assess the toxicity profile of each arm using the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) scale (V.3).

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Drug: FOLFOX 4 Drug: 5-FU / Cisplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Comparing Radiochemotherapy With the Folfox 4 Regimen Versus Radiochemotherapy With 5FU-Cisplatin (Herskovic Regimen) in First Line Treatment of Patients With Inoperable Esophageal Cancer
Study Start Date : September 2004
Actual Primary Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: FOLFOX 4
total treatment of six 2-weekly cycles of FOLFOX 4, the first 3 cycles starting on D1, D15 and D29 concomitant with 5 weeks' radiotherapy.

Active Comparator: 2 Drug: 5-FU / Cisplatin
two cycles of 5-FU / Cisplatin on week 1 and 5 of radiotherapy and two cycles of chemotherapy with 5-FU / Cisplatin on week 8 and 11 (one cycle each three weeks after the end of radiotherapy).

Primary Outcome Measures :
  1. Percentage of patients having completed the full treatment and Endoscopic complete response rate [ Time Frame: at the end of the study ]

Secondary Outcome Measures :
  1. Toxicity profile (NCI-CTC). [ Time Frame: evaluated each week ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

Patients with:

  • Histologically proven adenocarcinoma, squamous cell or adenosquamous carcinoma of the esophagus
  • Inoperable esophageal carcinoma (disease status: any T, N0 or N1, M0 or M1a) or surgical contraindication conditions
  • No prior treatment for esophageal cancer (surgery, laser, chemo- or radiotherapy)
  • Oesophageal dilatation is allowed before or during the treatment, but prior esophageal prosthesis is not allowed
  • Peripheral neuropathy <= NCI-CTC grade 1
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2
  • Sufficient (oral or with gastrostomy) calorific intake (> 1000 Kcal/m2/day)
  • Life expectancy >= 3 months
  • Adequate bone marrow reserve, normal renal and liver functions:

    • Neutrophil count >= 1500/mm³
    • Platelet count >= 100,000/mm³
    • Hemoglobin >= 10 g/dl (after transfusion, if necessary)
    • Creatinine levels <= 1.5 x the upper normal limit of institutional values (ULN)
    • Total bilirubin level < 1.5 x ULN
    • ALT/AST < 2.5 x ULN
    • Prothrombin time >= 60%
  • Laboratory values obtained the week preceding study entry
  • Signed informed consent (prior to all study procedures)
  • Start of treatment within 28 days of inclusion.

Exclusion Criteria:

  • Metastatic disease except for third upper or cervical esophagus tumor with regional nodes, or third lower esophagus tumor with celiac nodes (M1a)
  • Multiple carcinomas of the esophagus
  • Small cell or undifferentiated carcinoma of the esophagus
  • Complete dysphagia (grade 4 NCI-CTC); patient with exclusive parenteral nutrition.
  • Weight loss > 20% normal body weight
  • Pregnant or breast-feeding women
  • Fertile patient not using adequate contraception
  • Peripheral sensitive neuropathy with functional impairment
  • Auditory disorders
  • History of prior malignancies (other than cured non melanoma skin cancer, cured cervical carcinoma in situ or stage I or II node negative head and neck cancer cured > 3 years ago)
  • Prior cervical, thoracic and abdominal radiotherapy with field overlapping the proposed oesophageal radiotherapy field
  • Tracheo-oesophageal fistula or invasion of the tracheo-bronchial tree
  • Previous myocardial infarction (inferior or equal to 6 months). Patients with a previous myocardial infarction superior to 6 months, could be included only if: no transient ischemia is shown by thallium myocardial scintigraphy and favourable advice for chemotherapy is obtained from a cardiologist.
  • Other serious illness or medical conditions (such as symptomatic coronary disease, left ventricular failure or uncontrolled infection)
  • Arterial disease stage II to IV according to the Leriche and Fontaine classification
  • Treatment with any other experimental drugs or participation in another clinical trial within 30 days of study screening
  • Concurrent treatment with any other anti-cancer therapy
  • Concurrent treatment with phenytoin and yellow fever vaccine; geographical, social or psychological circumstances preventing regular follow-up.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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): NCT00160030

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Paris, France
Sponsors and Collaborators
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Study Director: Marie SEBILLE Sanofi

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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00160030     History of Changes
Other Study ID Numbers: L_9326
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents