Clinical trial · Interventional
Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy
Prospective Randomized Controlled Trial of Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy
NCT03734952CI-TRIAL-00069903recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 surgery with postoperative radiotherapy (PORT) versus surgery, in terms of the overall survival time (OS) in Stage II or III squamous cell esophageal carcinoma with neoadjuvant chemoradiotherapy(nCRT).
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 |
|---|---|---|---|
| Radiation Oncology | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esophagectomy program: | Procedure | — | UNRESOLVED |
| Neoadjuvant chemotherapy Program | Drug | — | UNRESOLVED |
| Neoadjuvant Radiotherapy Program: | Radiation | — | UNRESOLVED |
| Postoperative radiotherapy program | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program+Postoperative radiotherapy program
- interventionNames
- Radiation: Neoadjuvant Radiotherapy Program:
- Drug: Neoadjuvant chemotherapy Program
- Procedure: Esophagectomy program:
- Radiation: Postoperative radiotherapy program
- type
- OTHER
- label
- Group B
- description
- Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program
- interventionNames
- Radiation: Neoadjuvant Radiotherapy Program:
- Drug: Neoadjuvant chemotherapy Program
- Procedure: Esophagectomy program:
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must not have received any prior anticancer therapy Histologically-confirmed squamous cell carcinoma of the esophagus; 2. Tumors of the esophagus are located in the thoracic cavity; 3. Pre-treatment stageⅡ-Ⅲ (AJCC/UICC 8th Edition) 4. Male or non pregnant female 5. Age is between 18 years and 65 years, 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 or Karnofsky performance status (KPS) of 70 or more; 7. Adequate bone marrow function (White Blood Cells ≥4x109 /L; Neutrophil ≥1.5×109 /L; Hemoglobin≥ 90 g/L; platelets≥100x109 /L); 8. Adequate liver function (Total bilirubin, Aspartate transaminase(AST) and Alanine transaminase (ALT) ≤2x Upper Level of Normal (ULN)); 9. Adequate renal function (serum creatinine (SCr) ≤1.5 x ULN); 10. 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. Patients with another previous or current malignant disease； 4. Any patient with a significant medical condition which is thought unlikely to tolerate the therapies. Such as cardiac disease; 5. Age \>65 years; 6. Pregnant or lactating female or people during the birth-period who refused to take contraceptives; 7. Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior; 8. Patients who refuse surgery after neoadjuvant chemotherapy; 9. Unsuitable to be enrolled in the trial in the opinion of the investigators
References
Publications (8)
- BACKGROUNDChen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25. PMID 26808342
- BACKGROUNDYen YC, Chang JH, Lin WC, Chiou JF, Chang YC, Chang CL, Hsu HL, Chow JM, Yuan KS, Wu ATH, Wu SY. Effectiveness of esophagectomy in patients with thoracic esophageal squamous cell carcinoma receiving definitive radiotherapy or concurrent chemoradiotherapy through intensity-modulated radiation therapy techniques. Cancer. 2017 Jun 1;123(11):2043-2053. doi: 10.1002/cncr.30565. Epub 2017 Feb 2. PMID 28152166
- BACKGROUNDBurmeister BH, Thomas JM, Burmeister EA, Walpole ET, Harvey JA, Thomson DB, Barbour AP, Gotley DC, Smithers BM. Is concurrent radiation therapy required in patients receiving preoperative chemotherapy for adenocarcinoma of the oesophagus? A randomised phase II trial. Eur J Cancer. 2011 Feb;47(3):354-60. doi: 10.1016/j.ejca.2010.09.009. PMID 21084184
- 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
- BACKGROUNDCao XF, He XT, Ji L, Xiao J, Lv J. Effects of neoadjuvant radiochemotherapy on pathological staging and prognosis for locally advanced esophageal squamous cell carcinoma. Dis Esophagus. 2009;22(6):477-81. doi: 10.1111/j.1442-2050.2008.00910.x. PMID 19703071
- BACKGROUNDChen Y, Hao D, Wu X, Xing W, Yang Y, He C, Wang W, Liu J, Wang J. Neoadjuvant versus adjuvant chemoradiation for stage II-III esophageal squamous cell carcinoma: a single institution experience. Dis Esophagus. 2017 Jul 1;30(7):1-7. doi: 10.1093/dote/dox016.