Clinical trial · Interventional
Neoadjuvant Epirubicin, Cisplatin and Capecitabine (ECX) Followed by Definitive Chemoradiation With/Without Surgery for Squamous Cell Carcinoma of the Oesophagus
Neoadjuvant Epirubicin, Cisplatin and Capecitabine (Xeloda) [ECX] Followed by Definitive Chemoradiation With or Without Surgery for Patients With Newly Diagnosed Localized Squamous Cell Carcinoma of the Oesophagus
NCT00220129CI-TRIAL-00002896completedPhase 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 is a study to investigate the efficacy and safety of epirubicin, cisplatin and capecitabine (ECX) as neoadjuvant therapy prior to radical chemoradiotherapy using capecitabine and cisplatin as radio-sensitisers in patients with newly diagnosed localized squamous cell carcinoma of the oesophagus.
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 |
|---|---|---|---|
| Oesophageal Carcinoma | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epirubicin, Cisplatin, Capecitabine | Drug | — | UNRESOLVED |
| Surgical Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 2 year overall survival
Secondary outcomes (6)
- measure
- Objective clinical response rate assessed by computed tomography (CT), endoscopic ultrasound (EUS) and endoscopic biopsy
- measure
- Pattern of treatment failure
- measure
- Progression free survival
- measure
- Proportion of patients not achieving clinical complete response and requiring surgery after chemoradiation
- measure
- Treatment related toxicity
- measure
- Time to improvement of dysphagia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years. * Histologically verified squamous cell carcinoma of the cervical or thoracic oesophagus * American Joint Committee on Cancer (AJCC) Stage I-III (T1-3 N0-1 M0) (33), as assessed by spiral or multi-slice computed tomography (CT) and endoscopic ultrasound, where radical chemoradiation would be considered with curative intent. * No previous chemotherapy, radiotherapy or other investigational drug treatment for this indication. * World Health Organization (WHO) performance status 0,1 or 2. * Adequate bone marrow function with platelets \> 100 x 10\^9/l; white blood cells (WBC) \> 3 x 10\^9/l; neutrophils \> 1.5 x 10\^9/l at the time of study entry. * Serum bilirubin \< 35 micromol/l. * Serum creatinine \< 180 micromol/l and measured creatinine clearance over 60 ml/min. * No concurrent uncontrolled medical condition. * No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix in the last 10 years. * Life expectancy \> 3 months. * Adequate contraceptive precautions if relevant. * Informed written consent. Exclusion Criteria: * The presence of locally advanced or metastatic disease precluding curative chemoradiation (T4 or Stage IV or M1a-b) or disease not encompassable in a radical radiotherapy field. * Total dysphagia (O'Rourke's swallowing function scoring system 5) precluding swallowing of capecitabine even when crushed. * Medical or psychiatric conditions that compromise the patient's ability to give informed consent. * Intracerebral metastases or meningeal carcinomatosis. * New York Heart Association classification Grade III or IV. * Uncontrolled angina pectoris. * Pregnancy or breast feeding. * Impaired renal function with measured creatinine clearance less than 60 ml/min. * Previous investigational study drug * Known malabsorption syndromes * Patients with a known hypersensitivity to fluorouracil (5-FU) or with a dihydropyrimidine dehydrogenase (DPD) deficiency * Hearing loss
References
Publications (0)
Data not yet available
No reference posted for this study.