Clinical trial · Interventional
Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)
NCT04764227CI-TRIAL-00068508active not recruitingPhase 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 purpose of this study is to evaluate safety and 2-year local control rate for postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiotherapy | — | UNRESOLVED | — |
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Esophagus Cancer | Esophageal Neoplasm | PROBABILISTIC | 0.70 |
| Postoperative | — | UNRESOLVED | — |
| Radiation Therapy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Concurrent chemoradiotherapy group
- description
- Interventions: * Chemotherapy: Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw\*5 * Radiotherapy: A total dose of 50.4Gy will be delivered in 28 fractions at 1.8Gy/fraction, 5 fractions per week in 6 weeks. The CTV encompassed the bilateral supraclavicular, superior mediastinal, and subcarinal regions.
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Local control rate
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Joined the study voluntarily and signed informed consent form; * Age 18-75; * ECOG 0-2; * Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection; * The operative incision healed well; * T3-4N0M0, T1-4N1-3M0 (according to AJCC2009); * No radiotherapy, chemotherapy or other treatments pre (post) surgery; * PS ECOG 0-2; * Life expectancy of more than 3 months; * Hemoglobin (Hb) ≥ 9 g/dL, WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L, Platelet count (Pt) ≥ 100 x 109/L; * Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\< 1.5 x ULN; * Renal function: creatinine \< 1.5 x ULN * No immuno-deficiency; * Use of an effective contraceptive for adults to prevent pregnancy. Exclusion Criteria: * Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis; * Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years; * Participation in other interventional clinical trials within 30 days; * Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives; * Drug addiction, Alcoholism or AIDS; * Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior; * Unsuitable to be enrolled in the trial in the opinion of the investigators.
References
Publications (1)
- DERIVEDShen J, Ai D, Chen Y, Liu Q, Deng J, Hao S, Zhang X, Zhang J, Zhang Y, Chu L, Sun Y, Zhang Y, Xiang J, Miao L, Chen H, Zhu H, Zhao K. Postoperative chemoradiotherapy for esophageal squamous cell Carcinoma: Results from ESO-Shanghai 17 and joint analyses for phase II clinical trials. Clin Transl Radiat Oncol. 2025 Nov 21;57:101073. doi: 10.1016/j.ctro.2025.101073. eCollection 2026 Mar. PMID 41531940