FOLFOX-Cetuximab-radiotherapy for the Treatment of Esophageal Cancer

Study Overview
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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.

Official Title
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Phase II Trial of FOLFOX in Combination With Cetuximab and Concomitant Radiotherapy in the Treatment of Esophageal Cancer Stage III

Conditions
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Esophageal Cancer Stage III

Intervention / Treatment
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* Drug: radiochemotherapy,combination Cetuximab-FOLFOX


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>radiochemotherapy,combination Cetuximab-FOLFOX | Drug: radiochemotherapy,combination Cetuximab-FOLFOX<br>* objective response rate at 12 weeks with radiochemotherapy then combination Cetuximab-FOLFOX<br>* Other names: objective response rate,combination Cetuximab-FOLFOX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate (ORR) at 12 weeks with radiochemotherapy (first evaluation), and if applicable, within 2 to 4 weeks following the end of additional treatment with the combination Cetuximab-FOLFOX (second evaluation) |  | at 12 weeks and within 2 to 4 weeks following the end of additionnal treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival Quality of life Dysphagia score Overall survival toxicity of this regimen |  | during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal neoplasms, Cetuximab, Oxaliplatin, Fluorouracil, radiotherapy