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

Launched by ERASMUS MEDICAL CENTER · Jul 11, 2023

Keywords

ClinConnect Summary

The SANO trial is exploring a new approach for treating esophageal cancer that may help some patients avoid surgery. After patients receive a treatment called neoadjuvant chemoradiotherapy (which combines chemotherapy and radiation before surgery), the trial looks at whether active surveillance—watching the patient closely without immediate surgery—can be just as effective as the standard method that includes surgery. This approach is only offered to patients who show no signs of cancer spreading to other parts of the body but may have regrowth in the local area. The goal is to find out if this strategy can provide similar long-term survival rates while also being less invasive.

To participate in the trial, patients need to be at least 18 years old and have a form of esophageal cancer that has been confirmed through specific tests. They should have already started or be planning to start the neoadjuvant chemoradiotherapy treatment. However, those with certain conditions, like difficulties understanding the study or specific types of tumors, won’t be eligible. Participants in the trial can expect regular check-ups and assessments to monitor their condition closely. This study might not only change how esophageal cancer is treated but could also lead to better quality of life for many patients.

Gender

ALL

Eligibility criteria

• 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.