NCT06880289

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

PHASE II PROSPECTIVE RANDOMIZED TRIAL OF THE BOOST TREATMENT OF CHEMO-RADIOTHERAPY GUIDED BY PERFUSION MRI IMAGING ON HYPOXIC ZONES IN HEAD AND NECK CANCER

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (estimated)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 compared to standard chemoradiotherapy for squamous cell carcinomas of the head and neck. To evaluate whether side effects are influenced by the MRT approach. To search for initial (pre-treatment) hypoxic regions during treatment (at the 10th fraction of RT) in terms of volume and location. And finally to determine the prevalence and importance of pre-treatment hypoxic sub-regions and correlate the results with both clinical (primary site and tumor volume) and pathological (VEGF, EGFR and HIF-α expression in the primary tumor) characteristics.

Conditions

• Squamous Cell Tumors of the Head and Neck

Interventions

Type	Name	Description
DRUG	Cisplatin IV on days 1, 22, 43, at a dose of 100 mg/m2	Chemoradiotherapy will be performed from day 1 to day 49 regardless of the arm.

Timeline

• Start date: 2020-09-16
• Primary completion: 2024-07-31
• Completion: 2027-07-31
• First posted: 2025-03-17
• Last updated: 2025-03-17

Locations

2 sites across 1 country: Italy