- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04886635
Surgery As Needed for Oesophageal Cancer - 2 (SANO-2)
February 16, 2024 updated by: Bas P. L. Wijnhoven
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Estimated)
360
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Charlène vd Zijden, Drs.
- Phone Number: +31107041223
- Email: c.vanderzijden@erasmusmc.nl
Study Locations
-
-
Zuid-Holland
-
Rotterdam, Zuid-Holland, Netherlands, 3015 GD
- Recruiting
- Erasmus University Medical Center
-
Contact:
- Charlène vd Zijden
- Phone Number: +31107041223
- Email: c.vanderzijden@erasmusmc.nl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Including:
|
after the procedure/surgery and at least up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of distant and locoregional relapse
Time Frame: at least up to 2 years
|
Defined as the proportion of all patients with cCR who develop distant metastases either locoregional relapse
|
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
|
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
|
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
|
Patients with cCR at CRE-2, defined from date of diagnosis to date of all-cause death or to last day of follow-up
|
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
|
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
|
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
|
at least up to 2 years
|
|
Fear of recurrence of cancer
Time Frame: at least up to 2 years
|
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.
|
at least up to 2 years
|
Regret of the decision to undergo active surveillance
Time Frame: at least up to 2 years
|
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.
|
at least up to 2 years
|
Regret of the decision to undergo surgery
Time Frame: at least up to 2 years
|
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.
|
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
|
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
|
According to the SANO-2 study algorithm
|
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
|
Defined as PET-CT within 1 week followed by combined OGD and EUS
|
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
|
When taking bite-on-bite biopsies, a second biopsy is taken exactly at the same location of the first biopsy.
|
after the procedure and at least up to 2 years
|
The proportion of performed FNA in case of suspected lymph nodes
Time Frame: after the procedure and at least up to 2 years
|
Suspected lymph nodes are defined as round, hypoechoic and larger than 5 mm.
|
after the procedure and at least up to 2 years
|
The proportion of performed endoscopic reports which are complete
Time Frame: after the procedure and at least up to 2 years
|
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.
|
after the procedure and at least up to 2 years
|
The number of biopsies taken and quality of the biopsies
Time Frame: after the procedure and at least up to 2 years
|
after the procedure and at least up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bas Wijnhoven, Dr., Erasmus Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2021
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
January 1, 2029
Study Registration Dates
First Submitted
April 28, 2021
First Submitted That Met QC Criteria
May 10, 2021
First Posted (Actual)
May 14, 2021
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 16, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL76567.078.21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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