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Surgery As Needed for Oesophageal cancer -2

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26542
Enrollment
360
Registered
2021-03-09
Start date
2021-03-09
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Oesophageal cancer, oesofaguscarcinoom, esophageal cancer, active surveillance

Interventions

Patients will undergo two clinical response evaluations (CREs) after nCRT (i.e. CRE-1 and CRE-2). During CRE-1 at 5-6 weeks after nCRT patients will undergo oesophagogastroduodenoscopy (OGD) with bite

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

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

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

Secondary

MeasureTime 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.

Contacts

Public ContactCharlène van der Zijden

Erasmus MC

c.vanderzijden@erasmusmc.nl010 704 1223

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)