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FOLFOX-Cetuximab-radiotherapy for the Treatment of Esophageal Cancer

NCT ID: NCT00578201

Last Updated: 2011-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-02-28

Brief Summary

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This phase II trial is studying the effects of oxaliplatin, leucovorin and fluorouracil-when given together with Cetuximab and radiation therapy and radiation therapy to see how they work in treating patients with stage III esophageal cancer.

Detailed Description

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Cetuximab is a monoclonal antibody which can block the ability of tumor cells to grow and spread Cetuximab may also make tumor cells more sensitive to radiation therapy. Drug used in chemotherapy such as oxaliplatin leucovorin and Fluorouracil work in different way to stop the growth of tumor cells either by killing the cells or by stopping them form dividing. Radiation therapy uses high energy X rays to kill tumor cells. Giving cetuximab could improve the efficacy of chemotherapy and radiation therapy and may make the tumor smaller This phase II trial is studying the effects of oxaliplatin, leucovorin and fluorouracil-when given together with Cetuximab and radiation therapy and radiation therapy to see how they work in treating patients with stage III esophageal cancer.

Conditions

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Esophageal Cancer Stage III

Keywords

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Esophageal neoplasms Cetuximab Oxaliplatin Fluorouracil radiotherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

radiochemotherapy,combination Cetuximab-FOLFOX

Group Type EXPERIMENTAL

radiochemotherapy,combination Cetuximab-FOLFOX

Intervention Type DRUG

objective response rate at 12 weeks with radiochemotherapy then combination Cetuximab-FOLFOX

Interventions

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radiochemotherapy,combination Cetuximab-FOLFOX

objective response rate at 12 weeks with radiochemotherapy then combination Cetuximab-FOLFOX

Intervention Type DRUG

Other Intervention Names

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objective response rate,combination Cetuximab-FOLFOX

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed squamous cell carcinoma of the esophagus stage III (according to UICC classification)
* Measurable disease according to the RECIST criteria
* WHO performance status of 0 or 1
* Age 18-80 years old
* Reference imaging within the 2 weeks prior to the treatment
* Hematological and biochemical assessment within the 2 weeks prior to the treatment
* Neutrophils \>1.5 10 9/L, platelets \>150.10 9/L, Haemoglobin ≥10g/dL, Bilirubin ≤ 1.25 ULN, Aspartate Aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 ULN Woman of childbearing potential must use effective contraception methods Written informed consent obtained No prior chemotherapy or radiation therapy for esophageal cancer

Exclusion Criteria

* Stage I, II or IV (according to UICC classification)
* Esophageal carcinoma with small cells or endocrine cells or esophageal stromal tumor
* visceral metastasis
* orotracheal fistula weight loss \>15% within the previous 6 months Pregnancy or breast feeding Contra indication to the study treatment History of coronary heart disease uncontrolled, or myocardial necrosis within the previous 6 months
* Peripheral Neuropathy NCI \>1
* Liver Failure
* Prior thoracic radiation therapy
* history of cancer within the previous 5 years (except removed skin carcinoma, removed local melanoma located, and carcinoma cervix of uterus Esophageal Endoprosthesis
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Departement clinical research of the developpement

Principal Investigators

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Gérard LLEDO, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Clinique Saint Jean

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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P060503

Identifier Type: -

Identifier Source: org_study_id