MRI-Guided radiation boost shows promise for tough head and neck cancers
NCT ID NCT02031250
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested whether giving an extra dose of radiation to the most resistant parts of a tumor, identified by a special MRI scan (DCE-MRI), could improve outcomes for people with advanced head and neck cancer. 106 participants received standard chemoradiation (cisplatin or carboplatin plus IMRT) with or without the targeted boost. The goal was to see if the boost improved disease-free survival and local tumor control without increasing side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cisplatin or Carboplatin (chemotherapy) plus intensity-modulated radiation therapy (IMRT) with a boost to hypoperfused tumor volumes
- What this could lead to
- If successful, this approach could improve local tumor control and survival for patients with poor-prognosis head and neck cancer without increasing side effects.
- What could go wrong
- This is a phase 2 trial with only 106 participants, so results may not be definitive. The added radiation boost could increase toxicity, and the benefit may not be large enough to change standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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106 people
The number who actually took part.
- Start date
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Feb 2014
- Finished
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Feb 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have pathologically-confirmed, non-metastatic locally/regionally advanced squamous cell carcinoma of the head and neck, stage III/IV, referred for definitive chemo-RT, and meet one of the following six criteria: 1. Primary tumor (T4) with or without metastatic lymph nodes. Tumor or nodes are: unresectable, resection is considered by the treating surgeon or patient to result in unacceptable functional or oncological results, patient refuses surgery, or surgery is not possible due to comorbidities. 2. HPV(-) (Human Papillomavirus) or p16(-) locally/regionally advanced (T3-4 or N2-3) oropharyngeal cancer. 3. HPV(+) or p16(+) locally/regionally advanced (T4 or N3) oropharyngeal cancer. 4. T3 or T4 laryngeal or hypopharyngeal cancer that is locally advanced, bulky (\>40 cc\*), unresectable, or patient declines surgery. 5. Stage III/IV oral cavity or paranasal sinus cancers in patients who refuse surgery or are unfit for surgery. 6. Locally/regionally advanced (stage T3-4 and/or N3) nasopharyngeal cancer which is EBV (-) (Epstein-Barr Virus). * KPS (Karnofsky Performance Status: A measure of general well being and activities of daily living; scores range from 0 to 100 where 100 represents perfect health) \>70 (see Appendix A) within two weeks of enrollment. * Pre-treatment laboratory criteria within four weeks of enrollment: * WBC (White Blood Cell) \> 3500/ul, granulocyte \> 1500/ul. * Platelet count \> 100,000/ul. * Total Bilirubin \< 1.5 X ULN. * AST (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase) \< 2.5 X ULN. * Estimated Creatinine clearance \>30cc/min. * Patients must be able to receive protocol chemotherapy in the judgment of the treating Medical Oncologist. * Patients are adults (Age ≥18). * All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: * EBV (+) Nasopharyngeal Carcinoma in the protocol treated tumor. * Prior head and neck radiation. * Documented evidence of distant metastases. * Patients with active infection. * Pregnant women. * Patients should have no contraindications to having a contrast enhanced MRI scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Institutional Standard Practice.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
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Veterans Affairs (VA) Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105, United States
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Other studies related to the condition(s) this trial covers.
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