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van CCT (UK)

van CCT (UK)

Surgery As Needed for Oesophageal cancer.

- candidate number28160
- NTR NumberNTR6803
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-nov-2017
- Secondary IDsEMC17-392-SANO Erasmus MC
- Public TitleSurgery As Needed for Oesophageal cancer.
- Scientific TitleNeoadjuvant chemoradiotherapy plus surgery versus active surveillance for oesophageal cancer.
- hypothesisActive surveillance is non-inferior to surgery in patients with oesophageal cancer showing complete clinical response after neoadjuvant chemoradiotherapy.
- Healt Condition(s) or Problem(s) studiedEsophageal cancer
- Inclusion criteria- Patients who are planned to undergo 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, without distant dissemination;
- 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2017
- planned closingdate1-nov-2025
- Target number of participants300
- InterventionsApproximately 4-6 weeks after completion of nCRT all patients will undergo a first clinical response evaluation (CRE-I) consisting of endoscopy with (random) bite-on-bite biopsies of the primary tumour site and of any other suspected laesions in the oesophagus. Patients who are clinically complete responders (i.e. patients without local or disseminated disease proven by histology) will undergo a second clinical response evaluation (CRE-II), 6-8 weeks after CRE-I (i.e. 10-14 weeks after completion of nCRT). CRE-II will include a whole body 18F-FDG PET-CT, followed by endoscopy with (random) bite-on-bite biopsies of the primary tumour site and any other suspected laesions in the oesophagus, radial EUS for measurement of tumour thickness and ¨Carea and linear EUS plus FNA of suspected lymph nodes. Patients who have a clinically complete response after CRE-II will be assigned to either surgical resection or active surveillance. During the first phase of the study, these patients will undergo surgical resection, which is standard practice. After this phase, centres will change their policy to active surveillance, with the duration of the first phase determined randomly over the 12 centres (i.e. stepped wedge cluster design). Patients enrolled in the active surveillance arm will undergo diagnostic evaluations similar to CRE-II 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.
- Primary outcome- Overal survivall
- Secondary outcome- Percentage of patients in active surveillance arm who do not undergo surgery (i.e. patients who are cured by neoadjuvant chemoradiotherapy or who have occult distant metastases during initial staging.
- TimepointsSee interventions
- Trial web
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIES Berend Wilk, van der
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding, ZonMw
- Publications
- Brief summaryWe propose an active surveillance approach 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.
- Main changes (audit trail)
- RECORD8-nov-2017 - 30-nov-2017

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