Updated protocol of the SANO trial: a stepped-wedge cluster randomised trial comparing surgery with active surveillance after neoadjuvant chemoradiotherapy for oesophageal cancer.
Ben M EyckBerend J van der WilkBo Jan NoordmanBas P L WijnhovenSjoerd M LagardeHenk H HartgrinkPeter Paul L O CoeneJan Willem T DekkerMichail DoukasAte van der GaastJoos HeisterkampEwout A KouwenhovenGrard A P NieuwenhuijzenJean-Pierre E N PierieCamiel RosmanJohanna W van SandickMaurice J C van der SangenMeindert N SosefEdwin S van der ZaagManon C W SpaanderRoelf ValkemaHester F LingsmaEwout W SteyerbergJ Jan B van Lanschotnull nullPublished in: Trials (2021)
Substantial amendments were made prior to closure of enrolment of the SANO trial. These amendments do not affect the outcomes of the trial compared to the original protocol. The first results are expected late 2023. If active surveillance plus surgery as needed after neoadjuvant chemoradiotherapy for oesophageal cancer leads to non-inferior overall survival compared to standard oesophagectomy, active surveillance can be implemented as a standard of care.
Keyphrases
- rectal cancer
- study protocol
- locally advanced
- randomized controlled trial
- papillary thyroid
- phase iii
- minimally invasive
- phase ii
- clinical trial
- coronary artery bypass
- squamous cell
- lymph node
- healthcare
- radiation therapy
- squamous cell carcinoma
- surgical site infection
- palliative care
- lymph node metastasis
- type diabetes
- atrial fibrillation
- skeletal muscle
- metabolic syndrome
- free survival
- insulin resistance
- placebo controlled
- percutaneous coronary intervention
- chronic pain