Clinical trial · Observational
Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）
Clinical Evidence for Association of Neoadjuvant Chemotherapy or Chemoradiotherapy With Efficacy and Safety in Patients With Resectable Esophageal Carcinoma (NewEC Study)
NCT04027543CI-TRIAL-00045331completedClinicalTrials.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)
To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| Effect of Drugs | — | UNRESOLVED | — |
| Oesophageal Carcinoma | — | UNRESOLVED | — |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
| Safety Issues | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant chemoradiotherapy | Combination Product | — | UNRESOLVED |
| Neoadjuvant chemotherapy | Drug | — | UNRESOLVED |
| Oesophagectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Neoadjuvant chemoradiotherapy
- description
- Patients who had chemoradiotherapy before surgery.
- interventionNames
- Combination Product: Neoadjuvant chemoradiotherapy
- label
- Neoadjuvant chemotherapy
- description
- Patients who had chemotherapy before surgery.
- interventionNames
- Drug: Neoadjuvant chemotherapy
- label
- Surgery alone
- description
- Patients who only had oesophagectomy. Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic. The appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth.
- interventionNames
- Procedure: Oesophagectomy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically documented untreated SCC or adenocarcinoma of the oesophagus or gastro-oesophageal junction. * Patients clinically staged as stage I-III (T1-3, N0-1 and M0) as assessed by a contrast-enhanced multislice computed tomography (CT) scan, positron emission tomography, or endoscopic ultrasonography. * Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Exclusion Criteria: * Patients had received any previous treatment for oesophageal cancer. * Patients who were unsuitable for surgery because of comorbidities. * Patients had evidence of distant metastatic disease by history and physical examination.
References
Publications (1)
- DERIVEDZhou HY, Zheng SP, Li AL, Gao QL, Ou QY, Chen YJ, Wu ST, Lin DG, Liu SB, Huang LY, Li FS, Zhu HY, Qiao GB, Lanuti M, Yao HR, Yu YF. Clinical evidence for association of neoadjuvant chemotherapy or chemoradiotherapy with efficacy and safety in patients with resectable esophageal carcinoma (NewEC study). EClinicalMedicine. 2020 Jun 27;24:100422. doi: 10.1016/j.eclinm.2020.100422. eCollection 2020 Jul. PMID 32637899