Chemo-Radiotherapy Boost Treatment Guided by Perfusion MRI on Hypoxic Zones in Head and Neck Cancer

Launched by REGINA ELENA CANCER INSTITUTE · Mar 11, 2025

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ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with squamous cell tumors of the head and neck, specifically focusing on areas of the tumor that are not getting enough oxygen, known as hypoxic zones. The study aims to see if a more intense form of radiation therapy, guided by special imaging techniques, can improve the effectiveness of treatment compared to the standard approach. Researchers want to assess these tumor areas both before treatment starts and during the second week of radiation therapy.

To be eligible for this trial, participants must have a confirmed diagnosis of advanced squamous cell carcinoma in specific areas of the throat, like the oropharynx or larynx. They should be between the ages of 65 and 74 and meet certain health criteria to ensure they can safely receive the treatments. Participants will undergo specialized imaging and receive the intensified radiation treatment while being closely monitored. It's important to note that individuals with certain health conditions, allergies, or prior treatments may not qualify for this study. Overall, this trial aims to find better ways to treat challenging cancers and improve patient outcomes.

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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.