Clinical trial · Interventional
Oxaliplatin in Esophagus Cancer (Advanced) 1st Line
Phase II Open-label Single Arm Study of Oxaliplatin Combined With Cisplatin and 5FU in Advanced Esophagus Cancer Patients
NCT00259402CI-TRIAL-00002854completedPhase 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)
* To determine the activity and efficacy of the schema specified as dose regimen * To determine the safety and tolerability of the oxaliplatin-cisplatin and 5FU
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 |
|---|---|---|---|
| Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oxaliplatin
- interventionNames
- Drug: Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)
Primary outcomes (1)
- measure
- Efficacy endpoints include tumor response, progression free and overall survival.
- timeFrame
- Throughout the whole study
Secondary outcomes (1)
- measure
- Safety endpoints include summary of adverse events assessed by history, physical exams and laboratory evaluations.
- timeFrame
- Throughout the whole study duration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG 0-1 * Patients with histologically proven epidermoid carcinoma or adenocarcinoma of esophagus or stomach, with unresectable or metastatic disease; * No previous treatment with chemotherapy or radiotherapy * Measurable lesion (uni or bidimensional) Exclusion Criteria: * Creatinin clearance \<50 mL/min * Total bilirubin \>1.5\*ULN (Upper Limit of Normal) * AST/ALT \> 2.5\*ULN * Total White Blood Cell \<1.500.000/mL * Platelet count \<100.000.000/mL * symptomatic sensitive peripheral neuropathy * pregnant or breast-feeding women The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.