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
Sponsor study identifier
interventional
91
1 country
2
Study Start
September 16, 2020
Actual (reported)Primary Completion
July 31, 2024
Actual (reported)Study Completion
July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 16, 2020
Actual (reported)July 31, 2024
Actual (reported)March 11, 2025
Actual (reported)March 17, 2025
Actual (reported)July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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.
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.
Chemoradiotherapy will be performed from day 1 to day 49 regardless of the arm.
IRCSS Regina Elena
Roma, Roma, 00144, Italy
"Regina Elena" National Cancer Institute
Rome, Rome, 00144, Italy
Giuseppe Sanguineti, Doctor
IRCCS National Cancer Institute
First Submitted
March 11, 2025
First Posted
March 17, 2025
Study Start
September 16, 2020
Actual (reported)Primary Completion
July 31, 2024
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 5, 2026
Record last verified: 2026-06
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