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Surgery As Needed for Oesophageal Cancer - 2 (SANO-2)

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ClinicalTrials.gov Identifier: NCT04886635
Recruitment Status : Recruiting
First Posted : May 14, 2021
Last Update Posted : May 24, 2021
Sponsor:
Information provided by (Responsible Party):
Bas P. L. Wijnhoven, Erasmus Medical Center

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

Condition or disease Intervention/treatment
Cancer of Esophagus Other: Active surveillance

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.

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Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study on Active Surveillance After Neoadjuvant Chemoradiation for Oesophageal Cancer: SANO-2 Study
Actual Study Start Date : March 9, 2021
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2029

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Active surveillance
    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.


Primary Outcome Measures :
  1. 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:

    • 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  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. [ Time Frame: at least up to 2 years ]
  6. 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.

  7. 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.

  8. 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.

  9. 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 ]
  10. 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

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. The number of biopsies taken and quality of the biopsies [ Time Frame: after the procedure and at least up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04886635


Contacts
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Contact: Charlène vd Zijden, Drs. +31107041223 c.vanderzijden@erasmusmc.nl

Locations
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Netherlands
Erasmus University Medical Center Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015 GD
Contact: Charlène vd Zijden    +31107041223    c.vanderzijden@erasmusmc.nl   
Sponsors and Collaborators
Bas P. L. Wijnhoven
Investigators
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Principal Investigator: Bas Wijnhoven, Dr. Erasmus Medical Center
Publications:

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Responsible Party: Bas P. L. Wijnhoven, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04886635    
Other Study ID Numbers: NL76567.078.21
First Posted: May 14, 2021    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases