Clinical trial · Observational
Surgery As Needed for Oesophageal Cancer - 2
A Prospective Cohort Study on Active Surveillance After Neoadjuvant Chemoradiation for Oesophageal Cancer: SANO-2 Study
NCT04886635CI-TRIAL-00074116SANO-2recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A prospective cohort study on active surveillance after neoadjuvant chemoradiation for oesophageal cancer: SANO-2 study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Esophagus | Malignant Esophageal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active surveillance | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
- description
- 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
Secondary outcomes (15)
- measure
- Rate of distant and locoregional relapse
- timeFrame
- at least up to 2 years
- description
- Defined as the proportion of all patients with cCR who develop distant metastases either locoregional relapse
- measure
- Progression-free survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDShapiro 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
- BACKGROUNDNoordman 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
- BACKGROUNDNoordman 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
- DERIVEDvan 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.