Clinical trial · Interventional
Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer
Phase II Trial of Cetuximab, Irinotecan, Cisplatin (CPC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer
NCT00165490CI-TRIAL-00016029completedPhase 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)
The purpose of this study is to find out what effects (good and bad) the combination of three chemotherapy drugs (cetuximab, cisplatin, and irinotecan) have on esophageal cancer when given with radiation therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of Esophagus | Esophageal Adenocarcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of Esophagus | Esophageal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Radiation therapy | Device | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the response to the combination of cetuximab, cisplatin, irinotecan, and radiation therapy in resectable esophageal carcinoma.
- timeFrame
- 3 years
Secondary outcomes (2)
- measure
- To determine the safety of the drug combination and radiation therapy
- timeFrame
- 3 years
- measure
- To determine the progression-free survival of patients treated with combination chemotherapy and radiation therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Negative pregnancy test * Adenocarcinoma or squamous cell carcinoma of the esophagus, including the gastroesophageal junction, histologically confirmed, stage IIA, IIB and III. * ECOG performance status of 0 or 1. * Neutrophils greater or equal to 1,500/ul * Platelets greater or equal to 100,000/ul * Serum bilirubin less or equal to 1.5mg/ul * Serum creatinine less or equal to 1.5mg/ul * AST or SGOT less or equal to 2.5x upper normal limit * Alkaline phosphatase less or equal to 5x upper normal limit Exclusion Criteria: * Prior surgery for esophageal or gastro-esophageal junction cancer. * Prior chemotherapy or radiation therapy * Biopsy proven tumor invasion of the tracheobronchial tree or tracheo-esophageal fistula. * Metastatic disease to distant organs or non-regional lymph nodes. * Co-morbid disease that in the opinion of the investigator makes combined chemo-radiotherapy inadvisable. * Pregnant or lactating women * Other active malignancy * Patients with known Gilbert's Disease or interstitial pulmonary fibrosis. * History of seizure disorder * Uncontrolled diarrhea * Peripheral neuropathy (Grade 2) * Prior cetuximab or other therapy that specifically and directly targets the EGF pathway.
References
Publications (0)
Data not yet available
No reference posted for this study.