Surgery As Needed for Oesophageal Cancer - 2 (SANO-2)

Bas P. L. Wijnhoven

Status: Enrolling

Conditions: Cancer of Esophagus

Treatments: Other: Active surveillance

Study type: Observational

Funder types: Other

Identifiers

NCT04886635

NL76567.078.21

Details and patient eligibility

About

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

Full description

An active surveillance approach after completion of neoadjuvant chemoradiotherapy for locally advanced oesophageal cancer is being investigated in the SANO (Surgery As Needed for Oesophageal cancer) trial, that completed patient inclusion in December 2020. First long term results are expected end 2023. Based on current retrospective studies and short term results of the SANO, to date there is no evidence that active surveillance is unsafe. Within the follow-up of the SANO trial, the safety of active surveillance is continuously monitored. Based on a high participation rate (>90%) in the SANO trial and on the view of the Dutch patient federation for cancer of the digestive tract (SPKS) to offer active surveillance as an alternative treatment option in a controlled setting, there is a demand for a tailored surgery approach after neoadjuvant chemoradiotherapy until results of the SANO trial are available. When patients request active surveillance outside the SANO trial, it is of the utmost importance to set up a prospective cohort study (extension study) in order to monitor safety, implementation and effectiveness of active surveillance outside the SANO trial before the final results of the SANO trail are available.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.