Pre-Surgery If Needed for Oesophageal Cancer (preSINO)

  • STATUS
    Recruiting
  • days left to enroll
    42
  • participants needed
    400
  • sponsor
    Shanghai Chest Hospital
Updated on 15 February 2022
ct scan
cancer
endoscopy
carcinoma
squamous cell carcinoma
endoscopic ultrasound
chemoradiotherapy
esophageal cancer
pet/ct scan
esophagus cancer
squamous cell carcinoma of esophagus

Summary

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 curable esophageal squamous cell carcinoma (SCC).

Description

After neoadjuvant chemoradiotherapy (nCRT) for esophageal cancer, high pathologically complete response (pCR) rates are being achieved in patients with squamous cell carcinoma (SCC). An active surveillance strategy has been proposed for SCC patients with clinically complete response (cCR) after nCRT. To justify omitting surgical resection, patients with residual disease should be accurately identified.

The objective of this study is to assess the accuracy of response evaluations after nCRT based on the preSANO trial, including positron emission tomography with computed tomography (PET-CT), endoscopic bite-on-bite biopsies and endoscopic ultrasonography (EUS) with fine-needle aspiration (FNA) in patients with potentially curable esophageal SCC.

Operable esophageal SCC patients who are planned to undergo nCRT according to the CROSS regimen and are planned to undergo surgery will be recruited from four Asian centers. Four to six weeks after completion of nCRT, patients will undergo a first clinical response evaluation (CRE-1) consisting of endoscopic bite-on-bite biopsies. In patients without histological evidence of residual tumor (i.e. without positive biopsies), surgery will be postponed another six weeks. A second clinical response evaluation (CRE-2) will be performed 10-12 weeks after completion of nCRT, consisting of PET-CT, endoscopic bite-on-bite biopsies and EUS with FNA. Immediately after CRE-2 all patients without evidence of distant metastases will undergo esophagectomy. Results of CRE-1 and CRE-2 as well as results of single diagnostic modalities will be correlated to pathological response in the resection specimen for calculation of sensitivity, specificity, negative predictive value and positive predictive value.

If the current study shows that major residual disease (>10% residual carcinoma at the primary tumor site and any residual nodal disease) can be accurately (i.e. with sensitivity of 80.5%) detected in patients with esophageal SCC, a prospective trial will be conducted comparing active surveillance with standard esophagectomy in patients with a clinically complete response after nCRT (SINO trial).

Details
Condition Esophageal Cancer
Treatment First clinical response evaluation (CRE-1), Second clinical response evaluation (CRE-2)
Clinical Study IdentifierNCT03937362
SponsorShanghai Chest Hospital
Last Modified on15 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Patient with a second primary tumor
Previous major surgery in the chest or upper abdomen
Tumor not 18F-FDG-avid at baseline PET-CT
Suspected positive lymph nodes that cannot be covered by an uninterrupted radiation field that also includes the primary tumor area
Primary (early) lesion already removed by EMR/ESD
Previous history of chemotherapy and/or radiation therapy
Cervical esophageal cancer
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