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MRI-Guided radiation boost shows promise for tough head and neck cancers

NCT ID NCT02031250

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

106 people

The number who actually took part.

Start date

Feb 2014

Finished

Feb 2023

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109, United States

  • Veterans Affairs (VA) Ann Arbor Healthcare System

    Ann Arbor, Michigan, 48105, United States

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