Clinical trial · Interventional
Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma
Phase 2 Study of Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Patients With Advanced Esophageal Cancer
NCT02133612CI-TRIAL-00017488completedPhase 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)
Esophageal cancer is a highly aggressive malignancy with a poor overall outcome. * Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases. * No standard postoperative adjuvant chemotherapy has ever been established.
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 Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel; cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm paclitaxel and cisplatin
- interventionNames
- Drug: paclitaxel; cisplatin
Primary outcomes (1)
- measure
- 3 year overall survival
- timeFrame
- 5 year
Secondary outcomes (1)
- measure
- 3 year disease-free survival
- timeFrame
- 5 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ability to give informed consent * histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins * node-positive and pathologic stage M0 . * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Patients were enrolled 4 to 10 weeks after surgery. * Adequate organ function was required in 2 weeks of registration and was defined as: serum creatinine within normal institutional limit, and creatinine clearance (CrCl) ≥60ml/minute. Aspartate aminotransferase and bilirubin\<2 times of upper normal institutional limits. Exclusion Criteria: * prior chemotherapy or concurrent radiation therapy before esophagectomy * R1 or R2 resection * clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination
References
Publications (0)
Data not yet available
No reference posted for this study.