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

NCT06880289 | Active Not Recruiting Phase 2

• 1 other identifier: RS1308/20
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

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 compared to the standard IMRT approach.

Conditions

Squamous Cell Tumors of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• Complete response

  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

  2 years

Study Arms (2)

stIMRT standard IMRT regimen

ACTIVE COMPARATOR

In this treatment arm, chemoradiotherapy will be administered at doses of 70 Gy, 63 Gy and 58.1 Gy will be administered to PTV1, PTV2 and PTV3 respectively in 35 fractions (5 fractions per week) with simultaneous integrated boost (SIB) technique. Chemotherapy will consist of i.v. cisplatin on days 1, 22, 43, at a dose of 100 mg/m2. Hydration and antiemetics are controlled according to the Institute guidelines.

Drug: Cisplatin IV on days 1, 22, 43, at a dose of 100 mg/m2

deIMRT intensified IMRT regimen

EXPERIMENTAL

In the IMRT arm, the baseline HV dose (HV1) is further increased by 10% up to 77 Gy in 35 fractions (5 fractions per week) using SIB technique (2.2 Gy/fraction). Once the MR2 is performed at the 10th fraction, the hypoxic volumes (HV2) will be re-estimated and coregistered with the initial planning CT, if the HV2 is within the HV1, no change will be applied; if new hypoxic volumes are identified outside the initial HV1 volume, the plan will be adapted to boost these regions as well. Chemotherapy will consist of i.v. cisplatin on days 1, 22, 43, at a dose of 100 mg/m2. Hydration and antiemetics are controlled according to the Institute guidelines.

Drug: Cisplatin IV on days 1, 22, 43, at a dose of 100 mg/m2

Interventions

Cisplatin IV on days 1, 22, 43, at a dose of 100 mg/m2 DRUG

Chemoradiotherapy will be performed from day 1 to day 49 regardless of the arm.

Also known as: Radioterapia 70 Gy, 63 Gy e 58.1 Gy

deIMRT intensified IMRT regimen; stIMRT standard IMRT regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (2)

IRCSS Regina Elena

Roma, 00144, Italy

Location

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

Location

Study Officials

• Giuseppe Sanguineti, Doctor

  IRCCS National Cancer Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: September 16, 2020
• Primary Completion: July 31, 2024
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

IT (2)