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Response evaluation after chemoradiation for advanced oropharyngeal cancer using PET-CT and MRI


- candidate number19201
- NTR NumberNTR4704
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-jul-2014
- Secondary IDs2011/410 MEC
- Public TitleResponse evaluation after chemoradiation for advanced oropharyngeal cancer using PET-CT and MRI
- Scientific TitleResponse evaluation after chemoradiation for advanced oropharyngeal cancer using PET-CT and MRI
- ACRONYMREACTION
- hypothesisCurrent clinical practice is to perform response evaluation, i.e. examination under general anesthesia (EUA), routinely at 3 months after the end of treatment in patients who underwent chemoradiation for oropharyngeal cancer. Due the high response rates more than half of the patients are exposed to unnecessary biopsies. Biopsies in previously irradiated areas may induce complaints, e.g. pain, inflammation, wound healing problems, swallowing, dyspnea. Biopsies in previously treated areas may be false negative due to sampling errors within the residual mass. Besides aforementioned burden to the patient, such a examination under general anesthesia (EUA) requires hospital stay and operating facilities. The objective is to study the value of MRI and 18FDG-PET-CT in the detection of local residual oropharyngeal disease after chemoradiation to avoid futile routine examination under general anesthesia.
- Healt Condition(s) or Problem(s) studiedSquamous cell carcinoma of the head and neck (SSCHN), Squamous cell carcinoma (SCC), Head and Neck Squamous Cell Carcinoma
- Inclusion criteria• Oropharyngeal squamous cell carcinoma
• Initially resectable
• Scheduled for chemoradiation
• ‘Informed consent’ signed by patient
- Exclusion criteria• Age < 18 years
• Pregnancy
• Physical condition contra-indication salvage surgery
• Contra-indication for MRI
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mei-2012
- planned closingdate1-sep-2014
- Target number of participants50
- InterventionsPET-CT, MRI and examination under general anesthesia three months after treatment
- Primary outcomeThe primary endpoint is: accuracy with which diagnostic tests reduce the number of avoided futile EUAs.
- Secondary outcomeSecondary endpoints are: interobserver agreement, SUV (FDG-PET) and ADC (DW-MRI) thresholds, associated costs and burden of diagnostic procedures and health related quality of life.
- TimepointsPET-CT, MRI and examination under general anesthesia three months after treatment
- Trial web siten/a
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. C.S. Schouten
- CONTACT for SCIENTIFIC QUERIESDr. R. Bree, de
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryRationale: Current clinical practice is to perform response evaluation, i.e. examination under general anesthesia (EUA), routinely at 3 months after the end of treatment in patients who underwent chemoradiation for oropharyngeal cancer. Due the high response rates more than half of the patients are exposed to unnecessary biopsies. Biopsies in previously irradiated areas may induce complaints, e.g. pain, inflammation, wound healing problems, swallowing, dyspnea. Biopsies in previously treated areas may be false negative due to sampling errors within the residual mass. Besides aforementioned burden to the patient, such a examination under general anesthesia (EUA) requires hospital stay and operating facilities.
Objective: To study the value of MRI and 18FDG-PET-CT in the detection of local residual oropharyngeal disease after chemoradiation to avoid futile routine examination under general anesthesia.
Study design: Prospective observational non-randomized multicenter study.
Study population: Fifty patients with advanced stage but resectable squamous cell.
Intervention: (DW-)MRI, 18FDG-PET-CT and (routinely performed) examinations under general anesthesia (EUA) 3 months after chemoradiation. MRI is compared with pretreatment MRI.
Main study parameters/endpoints: The primary endpoint is accuracy with which diagnostic tests reduce the number of avoided futile EUAs.
Secondary endpoints are interobserver agreement, SUV (FDG-PET) and ADC (DW-MRI) thresholds, associated costs and burden of diagnostic procedures and health related quality of life.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In current clinical practice all these patients would already undergo imaging (MRI and/or PET) pre-treatment and 3 months after treatment. Radiation exposure due to repeated PET scanning is very low as compared to the radiation therapy of these patients. These patients may already benefit from PET and MRI due to improved diagnostic pretreatment and guidance (for eventual biopsy) during examination under general anesthesia. In the future patients may benefit from MRI and PET 3 months after chemoradiation to select reliably for examination under general anesthesia. Improved imaging may be helpful in diagnosing residual disease and avoiding futile examinations under general anesthesia.
- Main changes (audit trail)
- RECORD28-jul-2014 - 17-aug-2014


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