Clinical trial NCT00578201: FOLFOX-Cetuximab-radiotherapy for the Treatment of Esophageal Cancer
Official title: Phase II Trial of FOLFOX in Combination With Cetuximab and Concomitant Radiotherapy in the Treatment of Esophageal Cancer Stage III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer Stage III
Keywords: Esophageal neoplasms
Cetuximab
Oxaliplatin
Fluorouracil
radiotherapy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: GERCOR - Multidisciplinary Oncology Cooperative Group
First posted: 2007-12-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: at 12 weeks and within 2 to 4 weeks following the end of additionnal treatment
Secondary outcomes:
measure: Progression free survival Quality of life Dysphagia score Overall survival toxicity of this regimen
timeFrame: during the study
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique Saint Jean
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Gérard LLEDO, MD
role: PRINCIPAL_INVESTIGATOR
References: