To hear about similar clinical trials, please enter your email below
Trial Title:
Statistical Analysis Plan for the SANO-trial: Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Active Surveillance for Oesophageal Cancer
NCT ID:
NCT05953181
Condition:
Esophageal Cancer
Active Surveillance
Neoadjuvant Chemoradiotherapy
Surgical Oncology
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Active surveillance
Description:
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.
Arm group label:
Active surveillance
Arm group label:
Standard esophagectomy
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Erasmus MC, University Medical Center
Address:
City:
Rotterdam
Zip:
3015GD
Country:
Netherlands
Start date:
November 1, 2017
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05953181
