Surgery As Needed for Oesophageal Cancer - 2

Official title

A Prospective Cohort Study on Active Surveillance After Neoadjuvant Chemoradiation for Oesophageal Cancer: SANO-2 Study

Overview

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

Detailed description

An active surveillance approach after completion of neoadjuvant chemoradiotherapy for locally advanced oesophageal cancer is being investigated in the SANO (Surgery As Needed for Oesophageal cancer) trial, that completed patient inclusion in December 2020. First long term results are expected end 2023. Based on current retrospective studies and short term results of the SANO, to date there is no evidence that active surveillance is unsafe. Within the follow-up of the SANO trial, the safety of active surveillance is continuously monitored. Based on a high participation rate (\>90%) in the SANO trial and on the view of the Dutch patient federation for cancer of the digestive tract (SPKS) to offer active surveillance as an alternative treatment option in a controlled setting, there is a demand for a tailored surgery approach after neoadjuvant chemoradiotherapy until results of the SANO trial are available. When patients request active surveillance outside the SANO trial, it is of the utmost importance to set up a prospective cohort study (extension study) in order to monitor safety, implementation and effectiveness of active surveillance outside the SANO trial before the final results of the SANO trail are available.

Interventions

• Other Active surveillance
  Patients will undergo two clinical response evaluations (CREs) after nCRT. During CRE-1 (5-6 weeks) patients will undergo oesophagogastroduodenoscopy (OGD) with bite-on-bite biopsies. During CRE-2 (10-12 weeks) patients will undergo positron emission tomography with computed tomography (PET-CT), endoscopy with bite-on-bite biopsies and endoscopic ultrasonography (EUS) plus fine-needle aspiration (FNA). If cancer is detected, surgery will be performed. Patients with cCR are eligible for active su

Primary outcome measures

• Safety of active surveillance (including delayed surgery), measured by the number of patients with adverse events [Time frame: after the procedure/surgery and at least up to 2 years]

Secondary outcome measures (12)

• Rate of distant and locoregional relapse [Time frame: at least up to 2 years]
• Progression-free survival (PFS) [Time frame: From cCR until the date of first documented disease progression or date of death from any cause, whichever came first, assessed at least up to 2 years]
• Overall survival (OS) [Time frame: From cCR until the date of death from any cause, assessed at least up to 2 years]
• The proportion of patients in the active surveillance strategy that opted for decision counseling [Time frame: at least up to 2 years]
• The proportion of patients that opted for decision counselling as well as the proportion of patients who switched from preferring active surveillance to preferring immediate surgery or vice versa. [Time frame: at least up to 2 years]
• Fear of recurrence of cancer [Time frame: at least up to 2 years]
• Regret of the decision to undergo active surveillance [Time frame: at least up to 2 years]
• Regret of the decision to undergo surgery [Time frame: at least up to 2 years]
• The proportion of participating patients in the SANO-2 study who meet all eligibility criteria [Time frame: after the procedure and at least up to 2 years]
• The proportion of performed diagnostic modalities performed at appropriate time [Time frame: after the procedure and at least up to 2 years]
• The proportion of all performed CREs performed in correct order [Time frame: after the procedure and at least up to 2 years]
• The proportion of all performed endoscopies with at least 4 bite-on-bite biopsies taken [Time frame: after the procedure and at least up to 2 years]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Netherlands · 1 center

• Erasmus University Medical Center — Rotterdam

Publications

• Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW PMID 26254683
• Noordman BJ, Spaander MCW, Valkema R, Wijnhoven BPL, van Berge Henegouwen MI, Shapiro J, Biermann K, van der Gaast A, van Hillegersberg R, Hulshof MCCM, Krishnadath KK, Lagarde SM, Nieuwenhuijzen GAP, Oostenbrug LE, Siersema PD, Schoon EJ, Sosef MN, Steyerberg EW, van Lanschot JJB; SANO study group. Detection of residual disease after neoadjuvant chemoradiotherapy for oesophageal cancer (preSANO): PMID 29861116
• Noordman BJ, Wijnhoven BPL, Lagarde SM, Boonstra JJ, Coene PPLO, Dekker JWT, Doukas M, van der Gaast A, Heisterkamp J, Kouwenhoven EA, Nieuwenhuijzen GAP, Pierie JEN, Rosman C, van Sandick JW, van der Sangen MJC, Sosef MN, Spaander MCW, Valkema R, van der Zaag ES, Steyerberg EW, van Lanschot JJB; SANO-study group. Neoadjuvant chemoradiotherapy plus surgery versus active surveillance for oesophagea PMID 29409469
• van der Zijden CJ, Lagarde SM, Hermus M, Kranenburg LW, van Lanschot JJB, Mostert B, Nuyttens JJME, Oudijk L, van der Sluis PC, Spaander MCW, Valkema MJ, Valkema R, Wijnhoven BPL; SANO-2 study group. A prospective cohort study on active surveillance after neoadjuvant chemoradiotherapy for esophageal cancer: protocol of Surgery As Needed for Oesophageal cancer-2. BMC Cancer. 2023 Apr 10;23(1):327. PMID 37038138

Identifiers

NCT: NCT04886635 · NL76567.078.21

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗