Status:
ACTIVE_NOT_RECRUITING
Chemo-Radiotherapy Boost Treatment Guided by Perfusion MRI on Hypoxic Zones in Head and Neck Cancer
Lead Sponsor:
Regina Elena Cancer Institute
Conditions:
Squamous Cell Tumors of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
A randomized, prospective, phase II study conducted with the aim of evaluating whether the strategy of overdosing hypoxic sub-regions of the primary tumor is associated with better local control compa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT06880289
Start Date
September 16 2020
End Date
July 31 2027
Last Update
March 17 2025
Active Locations (2)
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1
IRCSS Regina Elena
Roma, Italy, 00144
2
"Regina Elena" National Cancer Institute
Rome, Italy, 00144