FOLFOX-Cetuximab-radiotherapy for the Treatment of Esophageal Cancer

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00578201

Collaborator

GERCOR - Multidisciplinary Oncology Cooperative Group (Other)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Stage III	Drug: radiochemotherapy,combination Cetuximab-FOLFOX	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 radiochemotherapy,combination Cetuximab-FOLFOX	Drug: radiochemotherapy,combination Cetuximab-FOLFOX objective response rate at 12 weeks with radiochemotherapy then combination Cetuximab-FOLFOX Other Names: objective response rate,combination Cetuximab-FOLFOX

Arm

Intervention/Treatment

Experimental: 1

radiochemotherapy,combination Cetuximab-FOLFOX

Drug: radiochemotherapy,combination Cetuximab-FOLFOX

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

Other Names:

objective response rate,combination Cetuximab-FOLFOX

Outcome Measures

Primary Outcome Measures

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

Progression free survival Quality of life Dysphagia score Overall survival toxicity of this regimen [during the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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