Statistical Analysis Plan for the SANO-trial: Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Active Surveillance for Oesophageal Cancer

Erasmus University

Status: Active, not recruiting

Conditions: Surgical Oncology; Esophageal Cancer; Neoadjuvant Chemoradiotherapy; Active Surveillance

Treatments: Procedure: Active surveillance

Study type: Interventional

Funder types: Other

Identifiers

NCT05953181

MEC 17-392

Details and patient eligibility

About

An active surveillance approach is proposed after completion of neoadjuvant chemoradiotherapy (nCRT) for carcinoma of the oesophagus. In this SANO (i.e. Surgery As Needed for Oesophageal cancer) approach, surgical resection is offered only to patients in whom a locoregional regrowth is highly suspected or proven, without distant dissemination. Such an organ-preserving strategy can have great advantages, but is only justified if long-term survival is non-inferior to that of the current standard trimodality approach comprising neoadjuvant chemoradiotherapy followed by standard surgery. The aim of this study is to assess the (cost-)effectiveness (including non-financial costs and survival) of active surveillance for patients with squamous cell- or adenocarcinoma of the oesophagus or oesophago-gastric junction.

Enrollment: 776 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who underwent or are planned to undergo neoadjuvant chemoradiotherapy according to CROSS and are planned to undergo potentially curative surgical resection for histologically proven oesophageal or junctional squamous cell carcinoma or adenocarcinoma are eligible. Whenever pathology is inconclusive but a multidisciplinary expert group concludes oesophageal carcinoma because of radiologically or endosonographically highly suspected lesions, patients are eligible for the study.
• Age ≥18;
• Written, voluntary, informed consent.

Exclusion criteria

• Language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent and to complete quality of life questionnaires;
• Non-FDG-avid tumour at baseline PET-CT scan;
• Initial treatment with endoscopic resection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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776 participants in 2 patient groups

Active surveillance

Experimental group

Treatment:

Procedure: Active surveillance

Standard esophagectomy

Active Comparator group

Treatment:

Procedure: Active surveillance