Clinical trial · Interventional
Phase II Trial of Neoadjuvant Treatment and Minimal Invasive Surgery for Esophageal and GEJ Cancer
Phase II Trial of Induction Chemotherapy Followed by Chemoradiotherapy With Paclitaxel and Carboplatin Before Minimal Invasive Surgery in Patients With Localized Esophageal and Gastro-esophageal Junction Cancer
- 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)
Phase II trial of induction chemotherapy with carboplatin AUC 6 plus paclitaxel 175 mg/m2 in a 21 day cycle for two cycles followed by radiotherapy 4500 cGy in 25 fractions plus carboplatin AUC=2 paclitaxel 50 mg/m2 in a week regimen followed by minimally invasive surgery after 6 to 10 weeks. A PET scan will be performed at the time of randomization and 14 days after de first cycle to determine the relation between metabolic response and survival.
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 Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Induction Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin paclitaxel | Drug | Carboplatin/Paclitaxel Regimen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- induction carboplatin paclitaxel
- description
- carboplatin AUC=6 21 day cycle for 2 cycles paclitaxel 175 mg/m2 21 day cycle for 2 cycles radiotherapy 4500 cGy in 25 fractions carboplatin AUC=2 in a week regimen during radiotherapy paclitaxel 50 mg/m2 in a week regimen during radiotherapy Minimal Invasive Surgery
- interventionNames
- Drug: carboplatin paclitaxel
Primary outcomes (1)
- measure
- complete pathological response
- timeFrame
- 2 weeks after surgery
- description
- complete pathological response will be evaluate in the surgical specimen after the neoadjuvant treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven adenocarcinoma or squamous cell carcinoma of the middle and lower third of the esophagus (included tumors located in the gastro-esophageal junction Siewert I and II) * Age between 18 and 75 years * Performance Status 0 or 1 * Stage (TNM AJCC 7th edition): cT1b-3, N0-1, M0 Exclusion Criteria: * History of another cancer, except skin non melanoma * Pregnancy * History of hypersensitivity to the study drugs
References
Publications (0)
Data not yet available