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Biologische tumorkenmerken voorspellend voor de respons op chemoradiotherapie bij slokdarmkanker


- candidate number22490
- NTR NumberNTR5323
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jul-2015
- Secondary IDsNL53633.099.15 CCMO
- Public TitleBiologische tumorkenmerken voorspellend voor de respons op chemoradiotherapie bij slokdarmkanker
- Scientific TitleMARKERS OF RESPONSE TO CHEMORADIATION IN ESOPHAGEAL CANCER Selection and validation of a panel of markers
- ACRONYMMORE
- hypothesisThe objective of the MORE studies is to select and validate a biomarker profile predictive for the response to weekly paclitaxel and carboplatin chemotherapy concomitant with radiotherapy in patients with esophageal cancer. In the MORE-1 pilot study candidate biomarkers are selected using a multimodal approach combining genomics (next generation sequencing) and proteonomics/kinomics (kinase activity profiling). The objective of the MORE-2 study is to validate the classifier that is developed in the MORE-1 study in patients treated with definitive chemo radiation (without surgery).
- Healt Condition(s) or Problem(s) studiedEsophageal cancer
- Inclusion criteriaAll patients referred to MCL with pathologically proven carcinoma of the esophagus and without distant metastases will be asked to participate
- Exclusion criterianone
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2015
- planned closingdate1-sep-2017
- Target number of participants85
- InterventionsStaging and treatment will be performed according to local and Dutch treatment guidelines. During the regular endoscopic ultrasonography (EUS) staging procedure 4 extra biopsies for biomarker testing will be taken from the primary esophageal tumor. One extra blood sample for genetic analyses purposes will be collected combined with a regular chemotherapy associated blood collection.
- Primary outcomeThe main study parameters are differences in kinetic profile and/or genetic profile between patients with and without a pathologic complete response after chemo radiation.
- Secondary outcomeThe association of the created predictive profile and relapse/survival outcome parameters
- Timepointsresponse after surgery en 2 year follow-up for diseasefree survival and overall survival
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESdr. W.E. Fiets
- CONTACT for SCIENTIFIC QUERIESdr. W.E. Fiets
- Sponsor/Initiator Medisch Centrum Leeuwarden (MCL)
- Funding
(Source(s) of Monetary or Material Support)
Stichting De Friesland
- Publications
- Brief summarySingle-centre study
- Main changes (audit trail)
- RECORD21-jul-2015 - 24-aug-2015


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