Clinical trial · Observational
Pre-Surgery If Needed for Oesophageal Cancer
Accuracy of Detecting Residual Disease After Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: the preSINO Trial (Pre-Surgery If Needed for Oesophageal Cancer)
NCT03937362CI-TRIAL-00086661preSINOcompletedClinicalTrials.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)
A prospective, multi-centre, diagnostic cohort study investigating the accuracy of positron emission tomography with computed tomography (PET-CT), endoscopic bite-on-bite biopsies and endoscopic ultrasonography (EUS) with fine-needle aspiration (FNA) for detecting residual disease after neoadjuvant chemoradiotherapy in patients with potentially resectable esophageal squamous cell carcinoma (SCC).
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 Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| First clinical response evaluation (CRE-1) | Diagnostic Test | — | UNRESOLVED |
| Second clinical response evaluation (CRE-2) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Clinical Response Evaluation
- description
- Patients with operable esophageal squamous cell carcinoma who are planned to undergo neoadjuvant chemoradiotherapy according to the CROSS regimen (intravenous carboplatin AUC 2 mg/mL/min and intravenous paclitaxel 50 mg/m2 on days 1, 8, 15, 22 and 29 with concurrent 41.4 Gy radiotherapy given in 23 fractions of 1.8 Gy on 5 days per week) followed by surgery. Patients will undergo a first clinical response evaluation (CRE-1) 4-6 week after completion of nCRT. In patients without histological evidence of residual tumor surgery will be postponed another 6 weeks. A second clinical response evaluation (CRE-2) will be performed 10-12 weeks after completion of nCRT. Immediately after CRE-2 all patients without evidence of distant metastases will undergo esophagectomy.
- interventionNames
- Diagnostic Test: First clinical response evaluation (CRE-1)
- Diagnostic Test: Second clinical response evaluation (CRE-2)
Primary outcomes (1)
- measure
- Accuracy of clinical response evaluations for detecting substantial residual locoregional disease
- timeFrame
- 10-12 weeks after completion of neoadjuvant chemoradiotherapy
- description
- The diagnostic performance in terms of sensitivity and specificity of both CRE-1 and CRE-2 for detecting TRG 3-4 residual tumor (more than 10% residual carcinoma) or TRG 1-2 residual tumor (less than 10% residual carcinoma) with residual nodal disease (ypN+) in the surgical resection specimen.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion criteria are: 1. Histologically confirmed esophageal squamous cell carcinoma; 2. Tumor located in the chest; 3. Clinical stage cT1N1-2M0, cT2-4aN0-2M0, according to the 8th Edition of the AJCC TNM classification for Esophageal Cancer; 4. Age \> 20 at the date of informed consent; 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of two or less; 6. Considered fit to undergo nCRT followed by surgical resection; 7. Expected survival time more than three months; 8. Written informed consent by the patient. Exclusion criteria are: 1. Patient with a second primary tumor; 2. Previous major surgery in the chest or upper abdomen; 3. Tumor not 18F-FDG-avid at baseline PET-CT; 4. Suspected positive lymph nodes that cannot be covered by an uninterrupted radiation field that also includes the primary tumor area; 5. Primary (early) lesion already removed by EMR/ESD; 6. Previous history of chemotherapy and/or radiation therapy; 7. Cervical esophageal cancer.
References
Publications (2)
- BACKGROUNDZhang X, Eyck BM, Yang Y, Liu J, Chao YK, Hou MM, Hung TM, Pang Q, Yu ZT, Jiang H, Law S, Wong I, Lam KO, van der Wilk BJ, van der Gaast A, Spaander MCW, Valkema R, Lagarde SM, Wijnhoven BPL, van Lanschot JJB, Li Z. Accuracy of detecting residual disease after neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma (preSINO trial): a prospective multicenter diagnostic cohort study. BMC Cancer. 2020 Mar 6;20(1):194. doi: 10.1186/s12885-020-6669-y. PMID 32143580
- DERIVEDLiu Z, Wang G, Yang Y, Su Y, Zhang H, Liu J, Cui P, Fan X, Yang J, Zhang Z, Gao X, Chao Y, Mostert B, van Lanschot JJB, Wijnhoven BPL, Law S, Li C, Cai S, Li Z. ctDNA detects residual disease after neoadjuvant chemoradiotherapy and guides adjuvant therapy in esophageal squamous cell carcinoma. Cell Rep Med. 2025 Sep 16;6(9):102334. doi: 10.1016/j.xcrm.2025.102334. Epub 2025 Sep 5. PMID 40914168