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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52368

Enrollment

900

Registered

2021-03-08

Start date

2021-03-11

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

carcinoma of the oesophagus oesophageal cancer

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the number of patients with adverse events registered in the SANO-2 study (safety).	—

Secondary

Measure	Time frame
Secondary endpoints are the proportion of patients that adhered to the SANO active surveillance protocol (implementation) and effectiveness of active surveillance outside the SANO trial.	—

Countries

Netherlands

Outcome results