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Table 1 Study algorithm

From: Neoadjuvant chemoradiotherapy plus surgery versus active surveillance for oesophageal cancer: a stepped-wedge cluster randomised trial

  Pretreatment CRE-I (4–6 weeks after nCRT) CRE-II (10–14 weeks after nCRT) Standard surgery arm (6, 9, 12, 16, 20, 24, 30, 36, 48 and 60 months after nCRT) Active surveillance arm (6, 9, 12, 16, 20, 24, 30, 36, 48 and 60 months after nCRT)
Informed consent X     
Inclusion    X   
Treatment allocationh    X   
ECOG performance status X X X X X
Endoscopy with bite-on-bite biopsies X X X   X
Radial EUS X   X   X
Linear EUS with FNA of suspected lymph nodes X   X   X
18F–FDG PET-CT (whole-body) X Xa Xb Xc Xb
Quality of Life (EQ-5D, QLQ-C30, QLC-OG25 en Cancer Worry Scale) X   X Xd Xd
Oesophagectomy   Xe Xf All At indicationg
  1. a18F–FDG PET-CT: during CRE-I, after OGD, only for clinically non-complete responders, to exclude disseminated disease
  2. b18F–FDG PET-CT: during CRE-II and active surveillance, prior to OGD and EUS, for all patients (all were clinically complete responders during CRE-I) to guide endoscopists in taken biopsies / FNA during OGD and EUS and to exclude disseminated disease
  3. c PET-CT in the standard surgery arm will be performed at 12 and 24 months after nCRT only, to exclude disseminated disaese
  4. dQuality of life will be assessed during the first 2 years only
  5. e Only for patients with locoregional disease
  6. f After CRE-II: Only for patients with cCR who are allocated to surgery
  7. g Only for patients in whom a locoregional regrowth is highly suspected or proven, without any signs of distant dissemination
  8. CRE: clinical response evaluation; nCRT: neoadjuvant chemoradiotherapy; ECOG: Eastern Cooperative Oncology Group EUS: endo-ultrasonograpy; FNA: fine needle aspiraton. hAt this point the patient will be allocated to one of the two treatment arms, dependent on the institution. Randomisation has already been performed at the institutional level and will be known to the patient at the moment of inclusion