Clinical trial · Interventional
Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial
NCT00213486CI-TRIAL-00107336completedPhase 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 standard non surgical therapy of locally advanced esophageal cancer is based on a definitive concurrent chemoradiotherapy regimen with fluorouracil and cisplatin. One of the alternative regimen which is being studied is the combination of a weekly cisplatin and irinotecan schedule with radiotherapy. This multicentric phase II clinical trial primarily aimed to evaluate the clinical complete response rate and secondary objectives were toxicity profile and survival.
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 Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- clinical complete response defined as no tumor detectable on esophagus endoscopy and no appearance of distant metastasis on CT scan
Secondary outcomes (2)
- measure
- toxicity profile
- measure
- overall survival rate at one and two years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * esophageal carcinoma (squamous cell or adenocarcinoma) histologically confirmed * performance status \<OR=2 (ECOG) * caloric intake\>1500 KCal/d * serum albumin \>32 gr/l * serum creatinine\<120 microgr/l * total serum bilirubin \< 1.5 mg/ml * no prior chemotherapy or radiotherapy or surgery for esophageal neoplasm * no prior history of malignancy other than cell carcinoma of the skin, in siyu cervical carcinoma, or head and neck carcinoma with complete response since 3 years * written informed consent Exclusion Criteria: * Gilbert's syndrome * cardiac disease as NYHA class 3 or 4 * myocardial infarction within the previous 6 months * metastatic disease * histologically proved invasion of tracheobronchial tree * metastatic disease
References
Publications (0)
Data not yet available
No reference posted for this study.