Clinical trial · Interventional
Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma
Chemotherapy Induction and Chemoradiotherapy Combined With Cetuximab Respectively in Patients With Non-Metastatic Esophageal Carcinoma: A Multicentric Phase II Study
NCT00735345CI-TRIAL-00017084terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): because of safety concerns the study was terminated prematurely
Summary
Brief summary (as posted)
The aim of this study is the evaluate the feasibility and safety of chemotherapy induction treatment combined with cetuximab followed by chemoradiotherapy combined with cetuximab in the treatment of patients with non-metastatic 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 | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Cetuximab | Biological | Cetuximab | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Radiation during chemoradio-immunotherapy | Radiation | — | UNRESOLVED |
| Taxotere | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- Chemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy
- interventionNames
- Drug: 5-FU
- Drug: Cisplatin
- Drug: Taxotere
- Biological: Cetuximab
- Radiation: Radiation during chemoradio-immunotherapy
Primary outcomes (2)
- measure
- Response rate
- timeFrame
- Duration of study
- measure
- Percentage of complete remissions and resection rate
- timeFrame
- Duration of study
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * histologically confirmed esophageal cancer (squamous cell carcinoma) * measurable, non-metastatic disease (uT1-4) * no previous cancer therapy (chemotherapy, radiotherapy or resection) * life expectancy \> 3 months * age \> 18 years * WHO Status ≤ 2 * negative pregnancy test for women of child-bearing potential, and use of adequate contraception * hematological status: neutrophiles ≥ 1,5x10E9/L, thrombocytes ≥ 100x10E9/L * adequate renal function: serum creatinine ≤ 1,5 x ULN * adequate liver function: alkaline phosphatase \< 2,5 x ULN, total bilirubin \< 1,5 x ULN Exclusion Criteria: * pregnant or nursing women * women of child-bearing potential without adequate contraception * concomitant anti-tumoral therapy except study mandated procedures * cervical esophageal cancer or diagnosis of metastases * participation in other clinical trials within the last 30 days * history of malignant disease within the last 5 years * peripheral neuropathy (NCI CTC ≥ grade 1) * concurrent active and serious non-malignant diseases: uncontrolled heart insufficiency, angina pectoris, hypertension or arrhythmias, liver disease, significant neurological or psychiatric conditions * active infections
References
Publications (0)
Data not yet available
No reference posted for this study.