Clinical trial · Interventional
Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Adjuvant Chemotherapy in the Treatment of the Lymph Node Positive Thoracic Esophageal Squamous Cell Carcinoma
Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma: A Randomized Phase 3 Trial
NCT02461043CI-TRIAL-00018996unknownPhase 3ClinicalTrials.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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel; cisplatin | Drug | — | UNRESOLVED |
| radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- chemotherapy and radiotherapy
- interventionNames
- Drug: paclitaxel; cisplatin
- Radiation: radiation
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- radiotherapy
- interventionNames
- Radiation: radiation
Primary outcomes (1)
- measure
- 3 year relapse free survival
- timeFrame
- 5 years
Secondary outcomes (1)
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.