Clinical trial NCT04886635: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer of Esophagus
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

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.

Primary outcomes:
measure: Safety of active surveillance (including delayed surgery), measured by the number of patients with adverse events
timeFrame: after the procedure/surgery and at least up to 2 years
Secondary outcomes:
measure: Rate of distant and locoregional relapse
timeFrame: at least up to 2 years
measure: Progression-free survival (PFS)
timeFrame: 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
measure: Overall survival (OS)
timeFrame: From cCR until the date of death from any cause, assessed at least up to 2 years
measure: The proportion of patients in the active surveillance strategy that opted for decision counseling
timeFrame: at least up to 2 years
measure: 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.
timeFrame: at least up to 2 years
measure: Fear of recurrence of cancer
timeFrame: at least up to 2 years
measure: Regret of the decision to undergo active surveillance
timeFrame: at least up to 2 years
measure: Regret of the decision to undergo surgery
timeFrame: at least up to 2 years
measure: The proportion of participating patients in the SANO-2 study who meet all eligibility criteria
timeFrame: after the procedure and at least up to 2 years
measure: The proportion of performed diagnostic modalities performed at appropriate time
timeFrame: after the procedure and at least up to 2 years
measure: The proportion of all performed CREs performed in correct order
timeFrame: after the procedure and at least up to 2 years
measure: The proportion of all performed endoscopies with at least 4 bite-on-bite biopsies taken
timeFrame: after the procedure and at least up to 2 years
measure: The proportion of performed FNA in case of suspected lymph nodes
timeFrame: after the procedure and at least up to 2 years
measure: The proportion of performed endoscopic reports which are complete
timeFrame: after the procedure and at least up to 2 years
measure: The number of biopsies taken and quality of the biopsies
timeFrame: after the procedure and at least up to 2 years
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Bas Wijnhoven, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5.
citation: 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): a prospective multicentre, diagnostic cohort study. Lancet Oncol. 2018 Jul;19(7):965-974. doi: 10.1016/S1470-2045(18)30201-8. Epub 2018 Jun 1.
citation: 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 oesophageal cancer: a stepped-wedge cluster randomised trial. BMC Cancer. 2018 Feb 6;18(1):142. doi: 10.1186/s12885-018-4034-1.