Surgery As Needed for Oesophageal Cancer - 2

NCT04886635 | Recruiting DMC

• 1 other identifier: NL76567.078.21
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer of Esophagus

Outcome Measures

Primary Outcomes (1)

• Safety of active surveillance (including delayed surgery), measured by the number of patients with adverse events

  Including: * Complications from OGD with bite-on-bite biopsies, EUS-FNA and PET-CT * Unresectable or incurable (T4b or R2) regrowth * Microscopically non-radical (R1) resection * Postoperative mortality (90 day- or in-hospital mortality) * Postoperative hospital stay of \>60 days * Postoperative complications, defined by the Esophagectomy Complications Consensus Group (ECCG) * Development of distant metastases

  after the procedure/surgery and at least up to 2 years

Secondary Outcomes (15)

• Rate of distant and locoregional relapse

  at least up to 2 years

• Progression-free survival (PFS)

  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)

  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

  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.

  at least up to 2 years

Interventions

Active surveillance OTHER

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 surveillance where regular CREs are performed to detect regrowth of cancer. Delayed oesophagectomy will be offered to patients with highly suspected or profen locoregional regrowth, without distant metastases. The safety and feasibility of active surveillance depends on several factors monitored in the SANO trial. So far, these stopping rules have not been met. In case one of the stopping rules is reached, further inclusion in the SANO-2 study will be stopped and surgical resection is offered.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bas P. L. Wijnhoven: lead

Study Sites (1)

Erasmus University Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Related Publications (4)

• 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.

  PMID: 26254683 BACKGROUND

• 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.

  PMID: 29861116 BACKGROUND

• 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.

  PMID: 29409469 BACKGROUND

• 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. doi: 10.1186/s12885-023-10747-z.

  PMID: 37038138 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Bas Wijnhoven, Dr.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlène vd Zijden, Drs.

CONTACT

+31107041223; c.vanderzijden@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 14, 2021
• Study Start: March 9, 2021
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)