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Cancer of EsophagusSANO-2NCT04886635

Surgery As Needed for Oesophageal Cancer - 2

An observational study of Cancer of Esophagus, run by Bas P. L. Wijnhoven at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer of Esophagus
What is being tested?
Active surveillance
How many people
360 participants
Where
1 siteNetherlands
Study dates
9 Mar 2021to 1 Jan 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Charlène vd Zijden, Drs. contact

+31107041223

c.vanderzijden@erasmusmc.nl

Netherlands1 site, 1 recruiting
  • Erasmus University Medical Center

    Rotterdam, South Holland, 3015 GD

    Charlène vd Zijden, +31107041223, c.vanderzijden@erasmusmc.nl

    Recruiting

Other trials in Netherlands

About this study

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

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

Read the 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.

Being tested
Active surveillance
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active surveillanceOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (15)
  1. Rate of distant and locoregional relapse

    Defined as the proportion of all patients with cCR who develop distant metastases either locoregional relapse

    Measured: at least up to 2 years

  2. Progression-free survival (PFS)

    Defined as the interval between cCR and the earliest occurrence of disease progression resulting in primarily (or peroperatively) unresectable disease, locoregional regrowth (after completion of therapy), distant dissemination (during or after completion of treatment) or all-cause death

    Measured: 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

  3. Overall survival (OS)

    Patients with cCR at CRE-2, defined from date of diagnosis to date of all-cause death or to last day of follow-up

    Measured: From cCR until the date of death from any cause, assessed at least up to 2 years

  4. The proportion of patients in the active surveillance strategy that opted for decision counseling

    Decision counseling is a conversation with a trained physician who can elicit, examine, and discuss the patient's preferences in such a way that the patients are enabled to reflect on all aspects of his/her preference

    Measured: at least up to 2 years

  5. 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.

    Measured: at least up to 2 years

  6. Fear of recurrence of cancer

    Assessed with the validated Cancer Worry Scale, including 8 items rated on a 4-point Likert scale ranging from "never" to "almost always." Scores range from 8 to 32. Higher scores indicate more frequent worries about cancer.

    Measured: at least up to 2 years

  7. Regret of the decision to undergo active surveillance

    Measured by the validated Decision Regret Scale, including 5 items rated on a 5-point Likert scale ranging from 1 ("strongly agree") to 5 ("strongly disagree"). Two of the statements (items 2 and 4) were phrased in the negative direction to avoid yea-saying bias. Scoring consisted of reversing the scores of the 2 negatively phrased items, then taking the mean of the 5 items. These means were converted to a score ranging from 0 to 100 by subtracting 1 and multiplying by 25. A score of 0 means no regret; a score of 100 means high regret.

    Measured: at least up to 2 years

  8. Regret of the decision to undergo surgery

    Measured by the validated Decision Regret Scale, including 5 items rated on a 5-point Likert scale ranging from 1 ("strongly agree") to 5 ("strongly disagree"). Two of the statements (items 2 and 4) were phrased in the negative direction to avoid yea-saying bias. Scoring consisted of reversing the scores of the 2 negatively phrased items, then taking the mean of the 5 items. These means were converted to a score ranging from 0 to 100 by subtracting 1 and multiplying by 25. A score of 0 means no regret; a score of 100 means high regret.

    Measured: at least up to 2 years

  9. The proportion of participating patients in the SANO-2 study who meet all eligibility criteria

    Measured: after the procedure and at least up to 2 years

  10. The proportion of performed diagnostic modalities performed at appropriate time

    According to the SANO-2 study algorithm

    Measured: after the procedure and at least up to 2 years

  11. The proportion of all performed CREs performed in correct order

    Defined as PET-CT within 1 week followed by combined OGD and EUS

    Measured: after the procedure and at least up to 2 years

  12. The proportion of all performed endoscopies with at least 4 bite-on-bite biopsies taken

    When taking bite-on-bite biopsies, a second biopsy is taken exactly at the same location of the first biopsy.

    Measured: after the procedure and at least up to 2 years

  13. The proportion of performed FNA in case of suspected lymph nodes

    Suspected lymph nodes are defined as round, hypoechoic and larger than 5 mm.

    Measured: after the procedure and at least up to 2 years

  14. The proportion of performed endoscopic reports which are complete

    OGD for anatomical landmarks which should be described, such as locations of the upper and lower tumour boundary, upper oesophageal sphincter, Z-line (where the squamous epithelium of the oesophagus meets the columnar epithelium), oesophagogastric junction (upper border of gastric folds) and diaphragmatic impression.

    Measured: after the procedure and at least up to 2 years

  15. The number of biopsies taken and quality of the biopsies

    Measured: after the procedure and at least up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2021
  2. Study start9 Mar 2021
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04886635
Sponsor's protocol ID
NL76567.078.21
Acronym
SANO-2
Status last verified
Feb 2024
First submitted
28 Apr 2021
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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, 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.

    PubMed 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): 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.

    PubMed 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 oesophageal cancer: a stepped-wedge cluster randomised trial. BMC Cancer. 2018 Feb 6;18(1):142. doi: 10.1186/s12885-018-4034-1.

    PubMed 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. doi: 10.1186/s12885-023-10747-z.

    PubMed 37038138

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer of Esophagus, run by Bas P. L. Wijnhoven at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Charlène vd Zijden, Drs. (+31107041223, c.vanderzijden@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04886635, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.

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