Clinical trial · Interventional
Comparison Between NCRT and NCT Followed by MIE for Treatment of Locally Advanced Resectable ESCC
Neoadjuvant Chemoradiotherapy VS. Neoadjuvant Chemotherapy Followed by Minimally Invasive Esophagectomy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma(cT3-4aN0-1M0):A Multi-center Prospective Randomized Clinical Trial
- 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 purpose of this study is to evaluate the outcomes of neoadjuvant chemoradiotherapy versus neoadjuvant chemotherapy followed by minimally invasive esophagectomy on patients with locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0).
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 Squamous Cell Carcinoma Stage cT3-4aN0-1M0 | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Minimally Invasive Esophagectomy | Procedure | — | UNRESOLVED |
| Neoadjuvant Chemoradiotherapy | Procedure | — | UNRESOLVED |
| Neoadjuvant Chemotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neoadjuvant chemoradiotherapy
- description
- Neoadjuvant chemoradiotherapy (NCRT) is performed followed by minimally invasive esophagectomy in enrolled patients.
- interventionNames
- Procedure: Neoadjuvant Chemoradiotherapy
- Procedure: Minimally Invasive Esophagectomy
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant chemotherapy
- description
- Neoadjuvant chemotherapy (NCT) is performed followed by minimally invasive esophagectomy in enrolled patients.
- interventionNames
- Procedure: Neoadjuvant Chemotherapy
- Procedure: Minimally Invasive Esophagectomy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically-confirmed squamous cell carcinoma of the esophagus; 2. Tumors of the esophagus are located in the thoracic cavity; 3. Pre-treatment stage as cT3-4aN0-1M0 (AJCC/UICC 7th Edition) (In case of stage cT4a, curative resectability has to be explicitly verified by the local surgical investigator prior to randomization). 4. Age is between 18 years and 75 years, 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 6. Adequate cardiac function. All patients should perform ECG, and those with a cardiac history or ECG abnormality should perform echocardiography with the left ventricular ejection fraction \> 50 %. 7. Adequate respiratory function with FEV1≥1.2L, FEV1%≥50% and DLCO≥50% shown in pulmonary function tests. 8. Adequate bone marrow function (White Blood Cells \>4x10\^9 /L; Neutrophil \>2.0×10\^9 /L; Hemoglobin \> 90 g/L; platelets\>100x10\^9 /L); 9. Adequate liver function (Total bilirubin \<1.5x Upper Level of Normal (ULN); Aspartate transaminase(AST) and Alanine transaminase (ALT) \<1.5x ULN); 10. Adequate renal function (Glomerular filtration rate (CCr) \>60 ml/min; serum creatinine (SCr) ≤120 µmol/L); 11. The patient has provided written informed consent and is able to understand and comply with the study; Exclusion Criteria: 1. Patients with non-squamous cell carcinoma histology; 2. Patients with advanced inoperable or metastatic esophageal cancer; 3. Pre-treatment stage as cT1-2N0-1M0 (AJCC/UICC 7th Edition); 4. Pre-treatment stage as cN2-3 or cT4b(non-curatively-resectable verified by the local surgical investigator, AJCC/UICC 7th Edition); 5. Patients with another previous or current malignant disease which is likely to interfere with treatment or the assessment of response in the judgement of the local surgical investigator. 6. Any patient with a significant medical condition which is thought unlikely to tolerate the therapies. Such as cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months), clinically-significant lung disease, clinically-significant bone marrow, liver, renal function disorder; 7. Pregnant or lactating women and fertile women who will not be using contraception during the trial; 8. Allergy to any drugs; 9. 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; 10. Expected lack of compliance with the protocol.
References
Publications (30)
- BACKGROUNDLuketich JD, Pennathur A, Awais O, Levy RM, Keeley S, Shende M, Christie NA, Weksler B, Landreneau RJ, Abbas G, Schuchert MJ, Nason KS. Outcomes after minimally invasive esophagectomy: review of over 1000 patients. Ann Surg. 2012 Jul;256(1):95-103. doi: 10.1097/SLA.0b013e3182590603. PMID 22668811
- BACKGROUNDStahl M, Walz MK, Stuschke M, Lehmann N, Meyer HJ, Riera-Knorrenschild J, Langer P, Engenhart-Cabillic R, Bitzer M, Konigsrainer A, Budach W, Wilke H. Phase III comparison of preoperative chemotherapy compared with chemoradiotherapy in patients with locally advanced adenocarcinoma of the esophagogastric junction. J Clin Oncol. 2009 Feb 20;27(6):851-6. doi: 10.1200/JCO.2008.17.0506. Epub 2009 Jan 12. PMID 19139439
- BACKGROUNDShen Y, Zhong M, Wu W, Wang H, Feng M, Tan L, Wang Q. The impact of tidal volume on pulmonary complications following minimally invasive esophagectomy: a randomized and controlled study. J Thorac Cardiovasc Surg. 2013 Nov;146(5):1267-73; discussion 1273-4. doi: 10.1016/j.jtcvs.2013.06.043. Epub 2013 Aug 28. PMID 23993028
- BACKGROUNDFeng M, Shen Y, Wang H, Tan L, Zhang Y, Khan MA, Wang Q. Thoracolaparoscopic esophagectomy: is the prone position a safe alternative to the decubitus position? J Am Coll Surg. 2012 May;214(5):838-44. doi: 10.1016/j.jamcollsurg.2011.12.047. Epub 2012 Mar 13. PMID 22421259
- BACKGROUNDShen Y, Zhang Y, Tan L, Feng M, Wang H, Khan MA, Liang M, Wang Q. Extensive mediastinal lymphadenectomy during minimally invasive esophagectomy: optimal results from a single center. J Gastrointest Surg. 2012 Apr;16(4):715-21. doi: 10.1007/s11605-012-1824-7. Epub 2012 Jan 19. PMID 22258878
- BACKGROUNDWang H, Feng M, Tan L, Wang Q. Comparison of the short-term quality of life in patients with esophageal cancer after subtotal esophagectomy via video-assisted thoracoscopic or open surgery. Dis Esophagus. 2010 Jul;23(5):408-14. doi: 10.1111/j.1442-2050.2009.01025.x. Epub 2009 Nov 23.