Active surveillance for oesophageal cancer after chemoradiotherapy
A Prospective Cohort Study on Active Surveillance After Neoadjuvant Chemoradiation for Oesophageal Cancer: SANO-2 Study
This study is testing whether closely monitoring patients with locally advanced oesophageal cancer after they finish chemoradiotherapy can be a safe and effective alternative to immediate surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT04886635 on ClinicalTrials.gov |
What this trial studies
This study investigates an active surveillance approach for patients with locally advanced oesophageal cancer who have completed neoadjuvant chemoradiotherapy. It aims to monitor the safety and effectiveness of this approach in a prospective cohort, as current evidence suggests that active surveillance may be a viable alternative to immediate surgery. The study is an extension of the SANO trial, which has shown high participation rates and a demand for tailored surgical approaches based on patient preferences. Continuous monitoring of safety and implementation will be conducted until the final results of the SANO trial are available.
Who should consider this trial
Good fit: Ideal candidates include operable patients aged 18 and older who have recently undergone neoadjuvant chemoradiotherapy for histologically proven oesophageal cancer.
Not a fit: Patients with non-FDG-avid tumors, those who have undergone endoscopic resection, or those requiring definitive chemoradiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with oesophageal cancer, potentially improving their quality of life.
How similar studies have performed: Other studies have shown promising results with active surveillance approaches in similar contexts, but this specific study is an extension and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion 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: * 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.
Where this trial is running
Rotterdam, South Holland
- Erasmus University Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Bas Wijnhoven, Dr. — Erasmus Medical Center
- Study coordinator: Charlène vd Zijden, Drs.
- Email: c.vanderzijden@erasmusmc.nl
- Phone: +31107041223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.