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Active Not Recruiting
NCT06880289
Chemo-Radiotherapy Boost Treatment Guided by Perfusion MRI on Hypoxic Zones in Head and Neck Cancer
Conditions: Squamous Cell Tumors of the Head and Neck
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 91
Sponsor: Regina Elena Cancer Institute
Location: IRCSS Regina Elena Roma Roma
Summary
To assess and localize hypoxic tumor subregions both at baseline and during the second week of radiotherapy. And to hypothesize that an intensified IMRT regimen may ensure higher local response rates compared to the standard IMRT approach.
Eligibility Criteria
Inclusion Criteria:
* histologically confirmed squamous cell carcinoma of the oropharynx, hypopharynx, or larynx;
* AJCC stage III or IV (cT2-4 N0-3 M0);
* specific informed consent.
Exclusion Criteria:
* Documented allergy to radiological contrast media or inability to receive contrast media due to concomitant pathology (e.g. renal);
* inability to receive radiotherapy (e.g. previous radiotherapy in the same region) and/or chemotherapy (inadequate bone marrow and/or liver and/or renal function);
* incomplete acquisition of MRI images;
* performance status 2 or more according to Zubrod;
* Previous invasive neoplasm (except skin cancer), except for neoplasms controlled for at least three years; non-invasive tumors (e.g. carcinoma in situ of the breast) are admitted even if diagnosed and treated in a period less than 3 years prior; patients with simultaneous or bilateral primary tumors are excluded;
* alcohol or drug abuse;
* legal incapacity or limited legal capacity;
* concomitant treatment with investigational drugs or participation in another clinical trial with use of investigational drugs within 30 days prior to screening for the study;
* documented hypersensitivity to study drugs or any of their excipients;
* pregnancy and/or breastfeeding.
Source: ClinicalTrials.gov (NCT06880289). StuddyBuddy aggregates publicly available trial information.