Back to resultsFOLFOX-Cetuximab-radiotherapy for the Treatment of Esophageal Cancer (FOLFOX)
Primary Purpose
Esophageal Cancer Stage III
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
radiochemotherapy,combination Cetuximab-FOLFOX
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer Stage III focused on measuring Esophageal neoplasms, Cetuximab, Oxaliplatin, Fluorouracil, radiotherapy
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
Sites / Locations
- Clinique Saint Jean
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
radiochemotherapy,combination Cetuximab-FOLFOX
Outcomes
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)
Secondary Outcome Measures
Progression free survival Quality of life Dysphagia score Overall survival toxicity of this regimen
Full Information
NCT ID
NCT00578201
First Posted
December 20, 2007
Last Updated
March 30, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
1. Study Identification
Unique Protocol Identification Number
NCT00578201
Brief Title
FOLFOX-Cetuximab-radiotherapy for the Treatment of Esophageal Cancer
Acronym
FOLFOX
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
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer Stage III
Keywords
Esophageal neoplasms, Cetuximab, Oxaliplatin, Fluorouracil, radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
radiochemotherapy,combination Cetuximab-FOLFOX
Intervention Type
Drug
Intervention Name(s)
radiochemotherapy,combination Cetuximab-FOLFOX
Other Intervention Name(s)
objective response rate,combination Cetuximab-FOLFOX
Intervention Description
objective response rate at 12 weeks with radiochemotherapy then combination Cetuximab-FOLFOX
Primary Outcome Measure Information:
Title
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)
Time Frame
at 12 weeks and within 2 to 4 weeks following the end of additionnal treatment
Secondary Outcome Measure Information:
Title
Progression free survival Quality of life Dysphagia score Overall survival toxicity of this regimen
Time Frame
during the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gérard LLEDO, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Saint Jean
City
Lyon
ZIP/Postal Code
69008
Country
France
12. IPD Sharing Statement
Learn more about this trial
FOLFOX-Cetuximab-radiotherapy for the Treatment of Esophageal Cancer
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