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NCT06880289Active, not recruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 5 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
91 (estimated)
First submitted
11 Mar 2025
Start date
16 Sept 2020
Primary completion date
31 Jul 2024
Lead sponsor
Regina Elena Cancer Institute
NCT number
NCT06880289

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 91
  • From 16 Sept 2020 to the primary completion date, 31 Jul 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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);
  • alcohol or drug abuse;
  • 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;

Other illness

  • 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;
  • documented hypersensitivity to study drugs or any of their excipients;

Other

  • incomplete acquisition of MRI images;
  • performance status 2 or more according to Zubrod;
  • legal incapacity or limited legal capacity;
  • pregnancy and/or breastfeeding.

Who the study is looking for

  • histologically confirmed squamous cell carcinoma of the oropharynx, hypopharynx, or larynx;
  • AJCC stage III or IV (cT2-4 N0-3 M0);
  • specific informed consent.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCSS Regina Elena
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Regina Elena National Cancer Institute
Coordinator of this site? Confirm its status
RomeItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.