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

Recruiting

• Conditions: carcinoma of the oesophagus; oesophageal cancer; 10017990; 10014713

• Registration Number: NL-OMON52368
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 900

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the number of patients with adverse events<br /><br>registered in the SANO-2 study (safety). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are the proportion of patients that adhered to the SANO<br /><br>active surveillance protocol (implementation) and effectiveness of active<br /><br>surveillance outside the SANO trial.</p><br>