Active Surveillance, Esophageal Cancer, Neoadjuvant Chemoradiotherapy, Surgical Oncology
Conditions
Brief summary
An active surveillance approach is proposed after completion of neoadjuvant chemoradiotherapy (nCRT) for carcinoma of the oesophagus. In this SANO (i.e. Surgery As Needed for Oesophageal cancer) approach, surgical resection is offered only to patients in whom a locoregional regrowth is highly suspected or proven, without distant dissemination. Such an organ-preserving strategy can have great advantages, but is only justified if long-term survival is non-inferior to that of the current standard trimodality approach comprising neoadjuvant chemoradiotherapy followed by standard surgery. The aim of this study is to assess the (cost-)effectiveness (including non-financial costs and survival) of active surveillance for patients with squamous cell- or adenocarcinoma of the oesophagus or oesophago-gastric junction.
Interventions
PROCEDUREActive surveillance
Patients enrolled in the active surveillance arm will undergo diagnostic evaluations every 3 months in the first year after completion of neoadjuvant treatment, every 4 months in the second year, every 6 months in the third year and yearly in the 4th and 5th year of follow up, or when symptoms or results of any diagnostic test require shorter assessment intervals. In the active surveillance arm, surgical resection will be offered only to those patients, in whom a locoregional regrowth is highly suspected or proven, without any signs of distant dissemination.
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients who underwent or are planned to undergo neoadjuvant chemoradiotherapy according to CROSS and are planned to undergo potentially curative surgical resection for histologically proven oesophageal or junctional squamous cell carcinoma or adenocarcinoma are eligible. Whenever pathology is inconclusive but a multidisciplinary expert group concludes oesophageal carcinoma because of radiologically or endosonographically highly suspected lesions, patients are eligible for the study. * Age ≥18; * Written, voluntary, informed consent.
Exclusion criteria
* Language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent and to complete quality of life questionnaires; * Non-FDG-avid tumour at baseline PET-CT scan; * Initial treatment with endoscopic resection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | the interval between the moment of achieving cCR (i.e. the moment the patient will start the intervention) and death or last follow-up, with a minimal follow-up of two years after reaching cCR. |
Countries
Netherlands
Outcome results
None listed