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

Inclusion Criteria3

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 Criteria4

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.

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.