ClinConnect ClinConnect Logo
Search / Trial NCT06880289

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

Trial Information

Current as of April 26, 2025

Active, not recruiting

Keywords

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.

Gender

ALL

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.

About Regina Elena Cancer Institute

The Regina Elena Cancer Institute is a leading research and treatment center dedicated to advancing oncology through innovative clinical trials and comprehensive patient care. Located in Rome, Italy, the institute is committed to enhancing cancer treatment methodologies and improving patient outcomes by fostering a collaborative environment among clinicians, researchers, and patients. With a focus on cutting-edge therapies and personalized medicine, the Regina Elena Cancer Institute plays a pivotal role in the global fight against cancer, contributing to significant breakthroughs in cancer research and treatment protocols.

Locations

Rome, , Italy

Roma, , Italy

Patients applied

0 patients applied

Trial Officials

Giuseppe Sanguineti, Doctor

Study Director

IRCCS National Cancer Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported