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Preoperative identification of response to neoadjuvant chemoradiotherapy for esophageal cancer.


- candidate number14842
- NTR NumberNTR3981
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-mei-2013
- Secondary IDs42022.041.13 CCMO
- Public TitlePreoperative identification of response to neoadjuvant chemoradiotherapy for esophageal cancer.
- Scientific TitlePreoperative identification of response to neoadjuvant chemoradiotherapy for esophageal cancer.
- ACRONYMPRIOR
- hypothesisAnatomical and functional magnetic resonance imaging (MRI) are of additional value to combined 18F-fluorodeoxyglucose positron emission tomography and computed tomography (PET-CT) in the evaluation of treatment response to neoadjuvant chemoradiation therapy for patients with esophageal cancer.
- Healt Condition(s) or Problem(s) studiedEsophageal cancer, PET-CT, MRI
- Inclusion criteria1. Histologically confirmed carcinoma of the esophagus or esophagogastric junction (i.e. tumors involving both cardia and esophagus on endoscopy);
2. Potentially resectable tumor (cT1b-4a N0-3 M0);
3. Undergoing neoadjuvant chemoradiation according to CROSS-regimen;
4. Age >18 years;
5. No history of other cancer or previous radiotherapy or chemotherapy;
6. Signed informed consent.
- Exclusion criteria1. Patients who meet exclusion criteria for MRI at 1.5T following the protocol of the Radiology department of the UMC Utrecht;
2. Glomerular Filtration Rate (GFR) of <45 mL/min/1.73m2, unless the patient has risk factors for contrast nefropathy according to the UMC Utrecht protocol ‘Preventie contrastreactie en contrast nefropathie, Versie 2 februari 2012’. In patients with risk factors a minimum GFR of 60 mL/min/1.73m2 will be required;
3. Patients with insulin dependent diabetes mellitus or a blood plasma glucose concentration higher than 10 mmol/L;
4. Patients with a known Gadovist allergy;
5. Patients with a known CT-contrast allergy;
6. Patients having difficulty understanding Dutch;
7. Pregnant or breast-feeding patients.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2013
- planned closingdate1-dec-2014
- Target number of participants30
- Interventions1. Three MRI scans: Pre-, per- and post-chemoradiation therapy;
2. Three PET-CT scans: Pre-, per- and post-chemoradiation therapy.
- Primary outcomeThe additional diagnostic value -in terms of accuracy, sensitivity, specificity and predicitve values- of anatomical and functional MRI to PET-CT in the evaluation of treatment response to neoadjuvant chemoradiation therapy for patients with esophageal cancer, as compared to the pathological specimen as gold standard.
- Secondary outcome1. Assessment of the optimal (MRI and PET-CT) imaging parameters that correlate best with pathological response;
2. Assessment of the optimal timing for the imaging series;
3. Assessment of the diagnostic value of MRI for post-nCRT restaging of T- and N-stage as compared to histopathology;
4. Assessment of the experienced burden for the patient associated with extra MRI and PET-CT scanning in the clinical work-up for esophageal cancer, as determined by a self-administered questionnaire.
- Timepoints1. Pre-chemoradiation: MRI and PET-CT;
2. 2 weeks after start of chemoradiation: MRI and PET-CT;
3. 1-2 weeks prior to surgery: MRI and PET-CT.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD2-mei-2013 - 14-mei-2013


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