Esophageal squamous cell carcinoma
Conditions
Interventions
A:neoadjuvant chemoradiotherapy plus minimally invasive surgery (McKoewn)
B:minimally invasive surgery (McKoewn) plus postoperative adjuvent therapy
Sponsors
Sichuan Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically-confirmed squamous cell carcinoma of the esophagus; 2. No prior therapy for malignant disease; 3. Endoscopic examination indicated that the upper margin of the tumor was located in the middle or lower thoracic esophagus; 4. Pre-treatment stage as cT2N2M0 or cT3-4aN0-2M0 (AJCC/UICC 8th Edition) (In case of stage cT4a, curative resectability has to be explicitly verified by the local surgical investigator prior to randomization). 5. Aged 18 years to 75 years; 6. Eastern Cooperative Oncology Group (ECOG) performance status 0–2; 7. Adequate cardiac, respiratory, liver , renal and bone marrow function; 8. The patient has provided written informed consent and is able to understand and comply with the study.
Exclusion criteria
Exclusion criteria: 1. Patients with non-squamous cell carcinoma histology; 2. Prior therapy for malignant disease; 3. Endoscopic examination indicated that the upper margin of the tumor was located in the upper thoracic esophagus; 4. Patients with advanced inoperable or metastatic esophageal cancer; 5. Any patient is thought unlikely to tolerate the surgery because of significant medical conditions with cardiac, respiratory, liver, renal and bone marrow function; 6. Participation in another intervention clinical trial with interference to the chemotherapeutic or chemoradiotherapeutic intervention during this study or during the last 30 days prior to informed consent; 7. Expected poor compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;2 years OS after surgery;3 years OS after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse reaction;Surgical perioperative complications;Surgical perioperative mortality;rate of protocol completion; | — |
Countries
China
Contacts
Public ContactYongtao Han
Sichuan Cancer Hospital & Institute
Outcome results
None listed