Clinical trial · Interventional
FOLFOX-Cetuximab-radiotherapy for the Treatment of Esophageal Cancer
Phase II Trial of FOLFOX in Combination With Cetuximab and Concomitant Radiotherapy in the Treatment of Esophageal Cancer Stage III
NCT00578201CI-TRIAL-00004636FOLFOXcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer Stage III | Malignant Esophageal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiochemotherapy,combination Cetuximab-FOLFOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- radiochemotherapy,combination Cetuximab-FOLFOX
- interventionNames
- Drug: radiochemotherapy,combination Cetuximab-FOLFOX
Primary outcomes (1)
- 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 (1)
- measure
- Progression free survival Quality of life Dysphagia score Overall survival toxicity of this regimen
- timeFrame
- during the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.