Clinical Trials in Italy / NCT06880289
Active, not recruiting
Phase 2
Chemo-Radiotherapy Boost Treatment Guided by Perfusion MRI on Hypoxic Zones in Head and Neck Cancer
NCT06880289 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Squamous Cell Tumors of the Head and Neck
Investigational drug(s) / intervention(s)
Cisplatin IV on days 1, 22, 43, at a dose of 100 mg/m2
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.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Complete response — 2 years
Complete response is defined as complete disappearance (100%) of tumor at any site (primary and nodal) on both physical examination and imaging. Any site (primary or nodal) suspicious for residual disease on re-evaluation imaging or physical examination will be confirmed by pathology
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| IRCSS Regina Elena | Roma | Roma | |
| "Regina Elena" National Cancer Institute | Rome | Rome |
More Regina Elena Cancer Institute trials in Italy
MALE Mamm Organoids
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06880289 on ClinicalTrials.gov ↗ ← All trials in Italy