Squamous Cell Carcinoma of the Head and NeckPhase 2NCT02031250
Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer
A Phase 2 study testing Cisplatin, Carboplatin and IMRT (Intensity-Modulated Radiation Therapy) in people with Squamous Cell Carcinoma of the Head and Neck, run by University of Michigan Rogel Cancer Center at 2 sites in United States.
Trial summary
This study aims to improve locoregional control of poor prognosis Head and Neck Cancer (HNC) patients by selectively escalating the radiotherapy dose to subvolumes of tumor likely to be resistant to standard Radiation Therapy (RT) using DCE-MRI (Dynamic Contrast Enhanced Magnetic Resonance Imaging). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Cisplatin, Carboplatin and IMRT (Intensity-Modulated Radiation Therapy)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to 22 Feb 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- HPV(-) (Human Papillomavirus) or p16(-) locally/regionally advanced (T3-4 or N2-3) oropharyngeal cancer.
- HPV(+) or p16(+) locally/regionally advanced (T4 or N3) oropharyngeal cancer.
- T3 or T4 laryngeal or hypopharyngeal cancer that is locally advanced, bulky (>40 cc*), unresectable, or patient declines surgery.
- Stage III/IV oral cavity or paranasal sinus cancers in patients who refuse surgery or are unfit for surgery.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Veterans Affairs (VA) Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
This study aims to improve locoregional control of poor prognosis Head and Neck Cancer (HNC) patients by selectively escalating the radiotherapy dose to subvolumes of tumor likely to be resistant to standard Radiation Therapy (RT) using DCE-MRI (Dynamic Contrast Enhanced Magnetic Resonance Imaging). Standard doses of radiotherapy to the rest of the tissues and surrounding normal tissues will be maintained.
- Being tested
- Cisplatin, Carboplatin, IMRT (Intensity-Modulated Radiation Therapy), Boost Radiation to Hypoperfused Volumes
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Cisplatin 40mg/m2 administered as an IV infusion prior to radiotherapy on day 1 of each week of chemo-irradiation
CarboplatinDrug
Patients considered medically unfit to receive Cisplatin as determined by the prescribing physician, will receive Carboplatin via IV infusion on day 1 of each week of chemo-irradiation
IMRT (Intensity-Modulated Radiation Therapy)Radiation
Boost Radiation to Hypoperfused VolumesRadiation
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) Receives: Drug: Cisplatin; Drug: Carboplatin; Radiation: IMRT (Intensity-Modulated Radiation Therapy) |
| Boost Arm | Experimental | Boost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) Receives: Drug: Cisplatin; Drug: Carboplatin; Radiation: IMRT (Intensity-Modulated Radiation Therapy); Radiation: Boost Radiation to Hypoperfused Volumes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DSF) Time- 2 Year Estimate
Kaplan-Meier curves with point-wise 90% confidence intervals will be generated for each treatment arm, overall and by strata. Estimates with confidence intervals will be generated from these curves for the usual summary statistics, including median DFS times.
Measured: 2 years post start of treatment
Secondary outcomes (4)
Local-regional Control Rate
Compare local-regional control rates between the two arms at 1, 2 and 3 years. Local-regional control is defined as the absence of local-regional progression. Locoregional failure (LRF) time was defined as the time from date of diagnosis to local or regional progression. Patients without LRF at last follow-up were censored at date of last follow-up.
Measured: 2 years post-treatment
Proportion of Patients in Which Hypoperfused/Low-diffusion Subvolumes Overlap With Recurrence Volumes
Measured: 3 years post treatment
Percent of Patients With Adverse Events
Acute and late toxicities will be summarized descriptively by grade and type for each treatment group. The Percent of patients experiencing certain toxicity types will be calculated with score based confidence intervals. Chi-square tests will be used to test whether the proportion of patients with toxicity differs between treatment groups. ACUTE TOXICITIES ≤3MONTHS AFTER RT. LATE TOXICITIES >3MONTHS AFTER RT
Measured: 3 years post treatment
Correlation Coefficient Between Continuous Dose and Perfusion Summary Measures
Pearson or Spearman rank based correlation between the continuous dose and perfusion summary measures
Measured: 2 weeks post Radiation Therapy (RT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completion22 Feb 2023
- Study completion22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michelle Mierzwa, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031250
- Sponsor's protocol ID
- UMCC 2013.062
- Other IDs
- HUM00074305, R01CA184153
- Status last verified
- Feb 2026
- First submitted
- 12 Dec 2013
- Last updated
- 2 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer
- ClinicalTrials.gov ID
- NCT02031250
- Acronym / sponsor ID
- UMCC 2013.062
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Feb 2014
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Posted 2 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to improve locoregional control of poor prognosis Head and Neck Cancer (HNC) patients by selectively escalating the radiotherapy dose to subvolumes of tumor likely to be resistant to standard Radiation Therapy (RT) using DCE-MRI (Dynamic Contrast Enhanced Magnetic Resonance Imaging). Standard doses of radiotherapy to the rest of the tissues and surrounding normal tissues will be maintained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Drug: Cisplatin, Drug: Carboplatin, Radiation: IMRT (Intensity-Modulated Radiation Therapy)Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) |
| Boost Arm | Experimental | Drug: Cisplatin, Drug: Carboplatin, Radiation: IMRT (Intensity-Modulated Radiation Therapy), Radiation: Boost Radiation to Hypoperfused VolumesBoost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- 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:
- Patients must be able to receive protocol chemotherapy in the judgment of the treating Medical Oncologist.
- Patients are adults (Age ≥18).
Key exclusion criteria (6 listed)
- EBV (+) Nasopharyngeal Carcinoma in the protocol treated tumor.
- Prior head and neck radiation.
- Documented evidence of distant metastases.
- Patients with active infection.
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisplatinCisplatin 40mg/m2 administered as an IV infusion prior to radiotherapy on day 1 of each week of chemo-irradiation | Drug | Boost Arm, Control Arm |
| CarboplatinPatients considered medically unfit to receive Cisplatin as determined by the prescribing physician, will receive Carboplatin via IV infusion on day 1 of each week of chemo-irradiation | Drug | Boost Arm, Control Arm |
| IMRT (Intensity-Modulated Radiation Therapy) | Radiation | Boost Arm, Control Arm |
| Boost Radiation to Hypoperfused Volumes | Radiation | Boost Arm |
Primary outcome
Disease Free Survival (DSF) Time- 2 Year Estimate
Time frame: 2 years post start of treatment
Kaplan-Meier curves with point-wise 90% confidence intervals will be generated for each treatment arm, overall and by strata. Estimates with confidence intervals will be generated from these curves for the usual summary statistics, including median DFS times.
4 secondary outcomes
Local-regional Control Rate
Time frame: 2 years post-treatment
Proportion of Patients in Which Hypoperfused/Low-diffusion Subvolumes Overlap With Recurrence Volumes
Time frame: 3 years post treatment
Percent of Patients With Adverse Events
Time frame: 3 years post treatment
Correlation Coefficient Between Continuous Dose and Perfusion Summary Measures
Time frame: 2 weeks post Radiation Therapy (RT)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Mierzwa, M.D. principal investigator
University of Michigan Rogel Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin, Carboplatin and IMRT (Intensity-Modulated Radiation Therapy) in people with Squamous Cell Carcinoma of the Head and Neck, run by University of Michigan Rogel Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (DSF) Time- 2 Year Estimate (time frame: 2 years post start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.