Clinical trial · Interventional
A Phase II Trial to Compare Efficacy and Safety of CRT VS Neo-CRT in Patients Who Achieved CCR for Esophageal Cancer
A Phase II Trial to Compare Efficacy and Safety of Definitive Radiochemotherapy VS Neoadjuvant Radiochemotherapy Plus Surgery in Patients Who Achieved Clinical Complete Response After Neoadjuvant Treatment for Stage II-III Esophageal 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)
Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care for patients with resectable locally advanced oesophageal cancer. Many studies suggest that definitive Radiochemotherapy(CRT) has similar efficacy as neoadjuvant chemoradiotherapy plus surgery for esophageal cancers who respond to chemoradiation. Herein, a single center prospective randomized phase II clinical trial will be carried out to compare efficacy and safety of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection in patients who achieved clinical complete response(CCR) after neoadjuvant radiochemotherapy for stage II-III esophageal Cancer.
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 |
|---|---|---|---|
| Stage II Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Definitive Radiochemotherapy | Radiation | — | UNRESOLVED |
| Neoadjuvant Radiochemotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Definitive Radiochemotherapy
- description
- Concurrent Radiochemotherapy: Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day.
- interventionNames
- Radiation: Definitive Radiochemotherapy
- Procedure: Neoadjuvant Radiochemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant Radiochemotherapy
- description
- Concurrent Radiochemotherapy: Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.
- interventionNames
- Radiation: Definitive Radiochemotherapy
- Procedure: Neoadjuvant Radiochemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Thoracic esophageal cancer patients or esophagocardial cancer patients, with locally advanced resectable tumor, clinically identified before treatment as T1-3N+M0 according to UICC(International Union Against Cancer) TNM(primary tumor, regional nodes, metastasis) Classification of Malignant Tumours, 7th ed. 2. Untreated patients who have not received any antitumor therapy 3. Life expectancy \>6 months 4. Age: 18-70 years 5. White blood cell count ≥4.0×109/l, ANC(absolute neutrophil count) ≥1.5×109/l, thrombocyte count ≥1011/l, hemoglobin ≥90 g/l; normal liver and kidney functions 6. WHO PS(Performance Status): 0-1 7. Patients who understood the study and gave signed informed consent Exclusion Criteria: 1. Patients who have already received antitumor therapy, including chemotherapy, radiotherapy or surgery; 2. Patients with hemorrhage or complicated hemorrhage 3. Other uncontrollable patients who are not suitable for surgery 4. Pregnant or lactating women 5. Patients who agree without acknowledgement as a result of psychological, family or social factors 6. Patients with CTCAE(Common Terminology Criteria Adverse Events Version 4.0) grade ≥2 peripheral neuropathy 7. Patients who have ever had malignant tumors other than esophageal cancer 8. Patients with a history of diabetes for \>10 years with unsatisfactory control of blood glucose level 9. Patients with serious heart, lung, liver or kidney dysfunction, hematopathy, immune system disease or cachexia who therefore cannot tolerate chemotherapy or surgery 10. Others.
References
Publications (1)
- DERIVEDQian D, Chen X, Shang X, Wang Y, Tang P, Han D, Jiang H, Chen C, Zhao G, Zhou D, Cao F, Er P, Zhang W, Li X, Zhang T, Zhang B, Guan Y, Wang J, Yuan Z, Yu Z, Wang P, Pang Q. Definitive chemoradiotherapy versus neoadjuvant chemoradiotherapy followed by surgery in patients with locally advanced esophageal squamous cell carcinoma who achieved clinical complete response when induction chemoradiation finished: A phase II random. Radiother Oncol. 2022 Sep;174:1-7. doi: 10.1016/j.radonc.2022.06.015. Epub 2022 Jun 25. PMID 35764191