Surgery As Needed for Oesophageal Cancer - 2
ConditionCancer of Esophagus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBas P. L. Wijnhoven
About this trial
A prospective cohort study on active surveillance after neoadjuvant chemoradiation for oesophageal cancer: SANO-2 study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Active surveillance
Other interventionPatients 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.
Treatment groups
No treatment groups listed
Trial outcomes
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
Time frame
after the procedure/surgery and at least up to 2 yearsSecondary outcomes
1
Rate of distant and locoregional relapse
Defined as the proportion of all patients with cCR who develop distant metastases either locoregional relapse
Time frame
at least up to 2 years2
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
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 years3
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
Time frame
From cCR until the date of death from any cause, assessed at least up to 2 years4
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
Time frame
at least up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bas P. L. Wijnhoven
Lead sponsor
Erasmus Medical Center
Sponsor institution
Source ClinicalTrials.gov