NCT03937362Completed
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)
Source: ClinicalTrials.gov · Last updated 3 Mar 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 1 May 2019
- Start date
- 8 Aug 2019
- Primary completion date
- 31 May 2023
- Lead sponsor
- Shanghai Chest Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03937362
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 8 Aug 2019 to the primary completion date, 31 May 2023
- 4 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous major surgery in the chest or upper abdomen;
- Suspected positive lymph nodes that cannot be covered by an uninterrupted radiation field that also includes the primary tumor area;
- Previous history of chemotherapy and/or radiation therapy;
Other illness
- Cervical esophageal cancer.
Other
- Patient with a second primary tumor;
- Tumor not 18F-FDG-avid at baseline PET-CT;
- Primary (early) lesion already removed by EMR/ESD;
Who the study is looking for
- Histologically confirmed esophageal squamous cell carcinoma;
- Tumor located in the chest;
- Clinical stage cT1N1-2M0, cT2-4aN0-2M0, according to the 8th Edition of the AJCC TNM classification for Esophageal Cancer;
- Age \> 20 at the date of informed consent;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of two or less;
- Considered fit to undergo nCRT followed by surgical resection;
- Expected survival time more than three months;
- Written informed consent by the patient.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Erasmus MC Cancer Institute Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Linkou District | Taiwan | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.