RecruitingNCT04886635

Surgery As Needed for Oesophageal Cancer - 2

A Prospective Cohort Study on Active Surveillance After Neoadjuvant Chemoradiation for Oesophageal Cancer: SANO-2 Study

Sponsor

Bas P. L. Wijnhoven

Enrollment

360 participants

Start Date

Mar 9, 2021

Study Type

OBSERVATIONAL

Conditions

Cancer of Esophagus

Summary

A prospective cohort study on active surveillance after neoadjuvant chemoradiation for oesophageal cancer: SANO-2 study.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether some patients with esophageal cancer who respond very well to chemotherapy and radiation treatment can safely skip surgery afterward. Researchers want to learn if watching closely and only operating when truly needed is a safe alternative to routine surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with esophageal cancer (squamous cell or adenocarcinoma, including tumors at the stomach-esophagus junction) - You have recently completed or are planning chemotherapy plus radiation (the CROSS regimen) before surgery - Your tumor showed up on a special type of scan (FDG-PET) - You are medically fit enough to undergo surgery if needed **You may NOT be eligible if...** - Your tumor did not show up on a PET scan at the start - Your cancer was first treated with an endoscopic procedure - You are receiving or planning to receive chemotherapy and radiation as your only treatment (without surgery planned) - You have difficulty with language, dementia, or another condition that prevents you from giving informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERActive surveillance

Patients will undergo two clinical response evaluations (CREs) after nCRT. During CRE-1 (5-6 weeks) patients will undergo oesophagogastroduodenoscopy (OGD) with bite-on-bite biopsies. During CRE-2 (10-12 weeks) patients will undergo positron emission tomography with computed tomography (PET-CT), endoscopy with bite-on-bite biopsies and endoscopic ultrasonography (EUS) plus fine-needle aspiration (FNA). If cancer is detected, surgery will be performed. Patients with cCR are eligible for active surveillance where regular CREs are performed to detect regrowth of cancer. Delayed oesophagectomy will be offered to patients with highly suspected or profen locoregional regrowth, without distant metastases. The safety and feasibility of active surveillance depends on several factors monitored in the SANO trial. So far, these stopping rules have not been met. In case one of the stopping rules is reached, further inclusion in the SANO-2 study will be stopped and surgical resection is offered.