Clinical trial · Interventional
Study of Neo-adjuvant Chemoradiotherapy Followed by Minimally Invasive Esophagectomy for Squamous Cell Esophageal Cancer
A Single Institution Prospective Randomized Controlled Clinical Trial of Neo-adjuvant Chemoradiotherapy Followed by Mckeown Minimally Invasive Esophagectomy (MIE) Versus Mckeown MIE for Locally Advanced Squamous Cell Esophageal 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)
The primary objective is to compare neo-adjuvant chemoradiotherapy followed by Mckeown Minimally Invasive Esophagectomy (MIE) Versus Mckeown MIE, pure radical chemoradiotherapy in terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell esophageal 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 |
|---|---|---|---|
| Squamous Cell Esophageal Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Mckeown MIE | Device | — | UNRESOLVED |
| Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- experimental group
- description
- Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
- interventionNames
- Procedure: Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
- type
- ACTIVE_COMPARATOR
- label
- Radical Chemoradiotherapy
- description
- only Radical Chemoradiotherapy
- interventionNames
- Drug: Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- Mckeown MIE
- description
- only Mckeown MIE
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIB or III, which is potentially resectable. 2. Patients must not have received any prior anticancer therapy. 3. More than 6 months of expected survival. 4. Age ranges from 18 to 70 years. 5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney. 6. Karnofsky performance status (KPS) of 90 or more. 7. Signed informed consent document on file. Exclusion Criteria: 1. Patients are diagnosed or suspected to be allergic to cisplatin or vinorelbine. 2. Patients with concomitant hemorrhagic disease. 3. Pregnant or breast feeding. 4. Inability to use gastric conduit after esophagectomy because of a prior surgery. 5. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more. 6. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.
References
Publications (0)
Data not yet available