Clinical trial · Interventional
A Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Esophageal Squamous Cell Carcinoma
A Multicenter, Randomized, Open-label, Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Patients Undergoing Radical Esophagectomy for Pathologic Lymph Node Positive Esophageal Squamous Cell Carcinoma
- 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)
This is a multicenter, randomized, open-label, phase III trail comparing adjuvant chemoradiotherapy (Paclitaxel and carboplatin) to adjuvant radiotherapy in patients undergoing radical esophagectomy for pathologic lymph node positive esophageal squamous cell carcinoma.
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 |
|---|---|---|---|
| Adjuvant radiotherapy | Radiation | — | UNRESOLVED |
| Paclitaxel and carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- adjuvant chemoradiotherapy
- description
- Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.
- interventionNames
- Radiation: Adjuvant radiotherapy
- Drug: Paclitaxel and carboplatin
- type
- EXPERIMENTAL
- label
- adjuvant radiotherapy
- description
- Adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy.
- interventionNames
- Radiation: Adjuvant radiotherapy
Primary outcomes (1)
- measure
- The overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically documented squamous cell carcinoma of the thoracic esophagus; undergoing radical esophagectomy; the pathological stage is T(primary tumor)1-4 N(regional lymph nodes)1-3 M(distant metastasis)0 (ESOPHAGUS, Union for International Cancer Control(UICC) 2010) ; 2. Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy); 3. The expectation of life is more than 6 months; 4. Age: 18\~70 years old; 5. Normal hemodynamic indices before the recruitment (including white blood cell count\>4.0×109/L, neutrophil count\>1.5×109/L, platelet count \>100×109/L, hemoglobin≥90g/l, normal liver/kidney function); 6. ECOG (Eastern Cooperative Oncology Group) : 0-1; 7. Able to understand this study and have signed informed consent. Exclusion Criteria: 1. Have been treated with chemotherapy, radiotherapy and other anti tumor treatment except surgery; 2. Known or suspected of allergy to paclitaxel or carboplatin; 3. Female in pregnancy or lactating; 4. With significant psychological, family, social and other factors which may affect the ability to understand and sign the informed consent; 5. Patients with peripheral neuropathy(CTC grade≥2); 6. With other malignant tumors before the recruitment. 7. The researchers consider that the patient is not appropriate to enroll the study; 8. The patient can't be tolerant to postoperative adjuvant radiotherapy and chemotherapy for serious heart/lung/liver/kidney function, the haematopoietic system diseases, the immune system diseases, the nervous system diseases, cachexia and so on.
References
Publications (0)
Data not yet available