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Clinical response evaluation after neoadjuvant chemoradiotherapy in esophageal cancer


- candidate number19634
- NTR NumberNTR4834
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-okt-2014
- Secondary IDsCCMO (ToetsingOnline) NL41732.078.13 
- Public TitleClinical response evaluation after neoadjuvant chemoradiotherapy in esophageal cancer
- Scientific TitleAccuracy of detecting residual disease after chemoradiotherapy preceding surgery for oesophageal cancer
- ACRONYMpreSANO trial
- hypothesisThe aim of this present diagnostic study is to determine the accuracy by which we can detect residual disease after neoadjuvant chemoradiotherapy.
- Healt Condition(s) or Problem(s) studiedEsophageal cancer, Chemoradiotherapy, Neoadjuvant chemoradiatian
- Inclusion criteriaPatients who are planned to undergo neoadjuvant chemoradiotherapy according to CROSS, followed by surgical resection for histologically proven oesophageal squamous cell carcinoma or adenocarcinoma are eligible for this study.

Written, voluntary informed consent
- Exclusion criteriaDementia or altered mental status prohibiting the understanding and giving of informed consent
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 22-jul-2013
- planned closingdate22-jul-2015
- Target number of participants120
- InterventionsApproximately 4-6 weeks after completion of nCRT all included patients will undergo a first clinical response evaluation (CRE-I) including endoscopy with (random) conventional mucosal biopsies of the primary tumour site and of any other suspected lesions in the oesophagus and radial EUS for measurement of tumour thickness and -area. Patients who are found to be clinically complete responders (i.e. those patients in whom no locoregional or disseminated disease can be proven by (cyto)histology) will be offered a postponed surgical resection, which will be scheduled approximately 6-8 weeks after CRE-I (i.e. approximately 12-14 weeks after completion of nCRT). In the 1-2 weeks preceding the postponed surgical resection a second clinical response evaluation (CRE-II) will be planned, which will include a whole body F18-FDG PET-CT, followed by endoscopy with (random) conventional mucosal biopsies of the primary tumour site and any other suspected lesions in the oesophagus, radial EUS for measurement of tumour thickness and ľarea and linear EUS plus FNA of suspected lymph nodes.
- Primary outcomeThe main study parameter is the correlation between the clinical response during CRE-I and CRE-II (CRE= clinical response evaluation) and the final pathological response in the resection specimen (as measured by the modified tumour regression grading system of Chirieac).
- Secondary outcomeR0-resection rates for all included patients that undergo resection.
- TimepointsSee "Interventions"
- Trial web sitewww.presano.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD B.J. Noordman
- CONTACT for SCIENTIFIC QUERIESMD B.J. Noordman
- Sponsor/Initiator Erasmus Medical Center, Academic Medical Center (AMC), Amsterdam, University Medical Center Utrecht (UMCU), Catharina Hospital Eindhoven, Atrium Medical Center, Heerlen
- Funding
(Source(s) of Monetary or Material Support)
Stichting Coolsingel
- Publications
- Brief summaryRationale: We propose a surgery as needed approach after completion of neoadjuvant chemoradiotherapy (nCRT) for carcinoma of the oesophagus. In this surgery as needed approach, patients will undergo close surveillance after completion of neoadjuvant chemoradiotherapy. Surgical resection would be offered only to those patients in whom a locoregional recurrence is highly suspected or proven, without any signs of distant dissemination. Such an organ-preserving strategy would clearly have great advantages, but only if long term survival would be comparable to that of the trimodality approach comprising neoadjuvant chemoradiotherapy followed by standard surgery. Before a surgery as needed approach can be tested in a randomised trial, we aim to determine the feasibility of accurate detection of residual disease after chemoradiotherapy.

Objective: The aim of this present diagnostic study is to determine the accuracy by which we can detect residual disease after neoadjuvant chemoradiotherapy. This study is set up as a prospective multi-centre feasibility trial, using a single arm.

Study design: non-randomised multi-centre feasibility trial

Study population: potentially operable patients with potentially curable squamous cell- or adenocarcinoma of the oesophagus or oesophago-gastric junction.

Intervention (if applicable): Approximately 4-6 weeks after completion of nCRT all included patients will undergo a first clinical response evaluation (CRE-I) including endoscopy with (random) conventional mucosal biopsies of the primary tumour site and of any other suspected lesions in the oesophagus and radial EUS for measurement of tumour thickness and -area. Patients who are found to be clinically complete responders (i.e. those patients in whom no locoregional or disseminated disease can be proven by (cyto)histology) will be offered a postponed surgical resection, which will be scheduled approximately 6-8 weeks after CRE-I (i.e. approximately 12-14 weeks after completion of nCRT). In the 1-2 weeks preceding the postponed surgical resection a second clinical response evaluation (CRE-II) will be planned, which will include a whole body F18-FDG PET-CT, followed by endoscopy with (random) conventional mucosal biopsies of the primary tumour site and any other suspected lesions in the oesophagus, radial EUS for measurement of tumour thickness and ľarea and linear EUS plus FNA of suspected lymph nodes.

Main study parameters/endpoints: the main study parameter is the correlation between the clinical response during CRE-I and CRE-II (CRE= clinical response evaluation) and the final pathological response in the resection specimen (as measured by the modified tumour regression grading system of Chirieac).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: the main burden for participating patients is to undergo one- or two rounds of diagnostic tests (clinical response evaluations, CRE) after completion of nCRT. Whether patients will undergo one- or two rounds will depend on whether residual disease is detected during the first CRE. These CREs will consist of endoscopy, endoscopic ultrasonography and PET-CT. All three tests carry a small risk of complications. There is no clear benefit for participating patients. However, for some patients the increased interval between the end of nCRT and surgery in this protocol will allow more time to gain strength and recover from nCRT before surgery.
- Main changes (audit trail)
- RECORD6-okt-2014 - 29-okt-2014


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