Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGOBSERVATIONAL

Surgery As Needed for Oesophageal Cancer - 2

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Operable patients who are planned to undergo or who recently underwent neoadjuvant chemoradiotherapy according to CROSS followed by surgical resection for histologically proven oesophageal squamous cell carcinoma or adenocarcinoma of the oesophagus or oesophago-gastric junction - Age ≥18 - Written, voluntary, willing to sign a consent form. Who Should NOT Join This Trial: - Non-FDG-avid tumour at baseline PET-CT scan - Initial treatment with endoscopic resection - Patients who underwent of who are planned to undergo definitive chemoradiotherapy - Language difficulty, dementia or altered mental status prohibiting the understanding and giving of willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Operable patients who are planned to undergo or who recently underwent neoadjuvant chemoradiotherapy according to CROSS followed by surgical resection for histologically proven oesophageal squamous cell carcinoma or adenocarcinoma of the oesophagus or oesophago-gastric junction * Age ≥18 * Written, voluntary, informed consent. Exclusion Criteria: * Non-FDG-avid tumour at baseline PET-CT scan * Initial treatment with endoscopic resection * Patients who underwent of who are planned to undergo definitive chemoradiotherapy * Language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent.

Treatments Being Tested

OTHER

Active 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.

Locations (1)

Erasmus University Medical Center
Rotterdam, South Holland, Netherlands