Clinical trial · Interventional
Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma
Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma - Carboplatin, Docetaxel and Capecitabine (CTX) or Epirubicin, Oxaliplatin and Capecitabine: a Randomised Phase 2 Trial.
NCT02177552CI-TRIAL-00037073SEEDunknownPhase 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 main purpose of this study is to determine the effects of treatment with carboplatin, docetaxel and capecitabine in patients with incurable cancer of the esophagus or stomach.
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 |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental chemotherapy
- description
- Intravenous carboplatin (C) AUC5 day 1 plus intravenous docetaxel (T) 60 mg/m2 day 1 plus oral capecitabine (X) 1000 mg/m2 twice daily from day 1-14, every 4 weeks.
- interventionNames
- Drug: Carboplatin
- Drug: Docetaxel
- Drug: Capecitabine
- type
- OTHER
- label
- Standard chemotherapy
- description
- Intravenous epirubicin (E) 50 mg/m2 day 1 plus intravenous oxaliplatin (O) 130 mg/m2 day 1 plus oral capecitabine (X) 625 mg/m2 twice daily continuously, every 3 weeks
- interventionNames
- Drug: Capecitabine
- Drug: Epirubicin
- Drug: Oxaliplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Key Inclusion Criteria: * Patients with histologically verified, unresectable or metastatic, HER2-negative, adenocarcinoma of the esophagus or stomach * Men or women less than 80 years of age * Performance status 0 or 1 * Life expectancy \>12 weeks * Adequate organ-function * Written informed consent Key Exclusion Criteria: * Prior chemotherapy for adenocarcinoma of the esophagus or stomach if the chemotherapy-free interval is less than 6 months * Progression on first-line chemotherapy for unresectable or metastatic adenocarcinoma of the esophagus or stomach * Chemotherapy with epirubicin, oxaliplatin, carboplatin, cisplatin or docetaxel less than 6 months before study entry * Prior cumulative dose of \>300 mg/m2 of epirubicin * Grade ≥ 2 side-effects from previous chemotherapy
References
Publications (1)
- DERIVEDPetersen PC, Petersen LN, Vogelius I, Bjerregaard JK, Baeksgaard L. A randomized phase 2 trial of first-line docetaxel, carboplatin, capecitabine (CTX) and epirubicin, oxaliplatin, capecitabine (EOX) in advanced esophagogastric adenocarcinoma. Acta Oncol. 2021 Jul;60(7):948-953. doi: 10.1080/0284186X.2021.1928281. Epub 2021 Jun 4. PMID 34086514