Clinical trial · Interventional
A Study to Compare Efficacy and Safety of DRT VS CRT Plus Surgery in Patients Who Achieved CCR for Esophageal Cancer
A Phase Ⅲ Trial to Compare Efficacy and Safety of Definitive Chemoradiation VS Neoadjuvant Chemoradiation Plus Surgery in Patients Who Achieved Clinical Complete Response After Neoadjuvant Treatment for Locally Advanced 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 esophageal 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 Ⅲ multicenter 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 resectable locally advanced 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 | Combination Product | — | UNRESOLVED |
| Neoadjuvant Radiochemotherapy | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Definitive Radiochemotherapy
- description
- Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day.
- interventionNames
- Combination Product: Definitive Radiochemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant Radiochemotherapy
- description
- Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.
- interventionNames
- Combination Product: Neoadjuvant Radiochemotherapy
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
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, 8th 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 who suffered from hemorrhage or complicated hemorrhage; 3. Other uncontrollable patients who are not suitable for surgery; 4. Female patients in pregnancy or lactation; 5. Patients who agree without acknowledgement due to psychic, family or social factors; 6. Patients who suffered from peripheral neuropathy, with CTC grade ≥2; 7. Patients who ever suffered from other types of malignant tumor other than esophagus cancer; 8. Patients who have diabetes history over 10 yrs and blood glucose level is not satisfyingly controlled; 9. Patients who suffer from serious malfunction of heart, lung, liver or kidney, hemotopathy, immune system disease or cachexia and therefore can't tolerate chemotherapy or surgery; 10. Others.
References
Publications (0)
Data not yet available