Clinical trial · Interventional
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
NCT06880289CI-TRIAL-00113779active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Tumors of the Head and Neck | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin IV on days 1, 22, 43, at a dose of 100 mg/m2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- stIMRT standard IMRT regimen
- description
- 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.
- interventionNames
- Drug: Cisplatin IV on days 1, 22, 43, at a dose of 100 mg/m2
- type
- EXPERIMENTAL
- label
- deIMRT intensified IMRT regimen
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.