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CompletedNCT02031250Updated Mar 2, 2026Results posted

Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer

A Phase 2 interventional study of Cisplatin and Carboplatin in Squamous Cell Carcinoma of the Head and Neck, sponsored by University of Michigan Rogel Cancer Center. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.

Sponsored by University of Michigan Rogel Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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). Standard doses of radiotherapy to the rest of the tissues and surrounding normal tissues will be maintained.

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Conditions studied

  • Squamous Cell Carcinoma of the Head and Neck
03

In context

Squamous Cell Carcinoma of Head and Neck

1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.

This study's enrollment of 106 is above the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Lead sponsor

University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.

Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
106 participants (actual)

Study arms

  • Active comparator
    Control Arm

    Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy)

    Drug: Cisplatin · Drug: Carboplatin · Radiation: IMRT (Intensity-Modulated Radiation Therapy)

  • Experimental
    Boost Arm

    Boost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy)

    Drug: Cisplatin · Drug: Carboplatin · Radiation: IMRT (Intensity-Modulated Radiation Therapy) · Radiation: Boost Radiation to Hypoperfused Volumes

Interventions

  • DrugCisplatin

    Cisplatin 40mg/m2 administered as an IV infusion prior to radiotherapy on day 1 of each week of chemo-irradiation

  • DrugCarboplatin

    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

  • RadiationIMRT (Intensity-Modulated Radiation Therapy)
  • RadiationBoost Radiation to Hypoperfused Volumes
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years post start of treatment

Secondary outcomes

  1. 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.

    Time frame: 2 years post-treatment

  2. Proportion of Patients in Which Hypoperfused/Low-diffusion Subvolumes Overlap With Recurrence Volumes

    Time frame: 3 years post treatment

  3. 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

    Time frame: 3 years post treatment

  4. Correlation Coefficient Between Continuous Dose and Perfusion Summary Measures

    Pearson or Spearman rank based correlation between the continuous dose and perfusion summary measures

    Time frame: 2 weeks post Radiation Therapy (RT)

07

Results

Posted Mar 2, 2026

Participant flow

Participant flow — Overall Study
MilestoneControl ArmBoost Arm
Started5941
Completed5440
Not completed51
Withdrew: Noncompliance11
Withdrew: Withdrawal by subject40

Outcome measures

PrimaryDisease 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.

Time frame:
2 years post start of treatment
Reported as:
Median · days
Disease Free Survival (DSF) Time- 2 Year Estimate
daysControl ArmBoost Arm
Disease Free Survival (DSF) Time- 2 Year Estimate48 (34 to 60)57 (43 to 69)
SecondaryLocal-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.

Time frame:
2 years post-treatment
Reported as:
Number · participants
Local-regional Control Rate
participantsControl ArmBoost Arm
Local-regional Control Rate157
SecondaryProportion of Patients in Which Hypoperfused/Low-diffusion Subvolumes Overlap With Recurrence Volumes
Time frame:
3 years post treatment
Reported as:
Count of participants · Participants
Proportion of Patients in Which Hypoperfused/Low-diffusion Subvolumes Overlap With Recurrence Volumes
ParticipantsControl ArmBoost Arm
Proportion of Patients in Which Hypoperfused/Low-diffusion Subvolumes Overlap With Recurrence Volumes1212
SecondaryPercent 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

Time frame:
3 years post treatment
Reported as:
Number · Percent of patients
Percent of Patients With Adverse Events
Percent of patientsControl ArmBoost Arm
ACUTE TOXICITIES - Hospitalization21.925.6
ACUTE TOXICITIES- Interrupted chemotherapy24.423.1
ACUTE TOXICITIES- feeding tube24.438.5
ACUTE TOXICITIES- Pain requiring long active narcotics43.952.6
ACUTE TOXICITIES- RT delay2.50
ACUTE TOXICITIES- Dehydration requiring IVF Support53.746.2
ACUTE TOXICITIES- Grade 2+ mucositis8073
ACUTE TOXICITIES- Grade 3+ mucositis9.810.0
ACUTE TOXICITIES- Grade 3+ dermatitis2.47.5
LATE TOXICITIES- Aspiration Pneumonia17.512.5
LATE TOXICITIES- Pain requiring narcotics29.330.8
LATE TOXICITIES- Grade 3+ Xerostomia00
LATE TOXICITIES- feeding tube11.86.9
LATE TOXICITIES- Grade 3+ dysgeusia lasting 12 months00
LATE TOXICITIES- osteoradionecrosis managed medically05
LATE TOXICITIES- Osteoradionecrosis requiring debridement/surgery9.812.5
LATE TOXICITIES- Lymphedema requiring referral to OT41.042.5
LATE TOXICITIES- Fetal Oral Hemorrhage05.0
SecondaryCorrelation Coefficient Between Continuous Dose and Perfusion Summary Measures

Pearson or Spearman rank based correlation between the continuous dose and perfusion summary measures

Time frame:
2 weeks post Radiation Therapy (RT)

No measurements were reported for this outcome.

Adverse events

Collected over All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 3 years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control Arm14/59 (23.7%)15/59 (25.4%)59/59 (100%)
Boost Arm15/41 (36.6%)12/41 (29.3%)38/41 (92.7%)
Most frequent serious events
Showing 10 of 26
Most frequent serious events
EventControl ArmBoost Arm
VomitingGastrointestinal disorders0/593/41
Febrile neutropeniaBlood and lymphatic system disorders3/591/41
NauseaGastrointestinal disorders0/592/41
AspirationRespiratory, thoracic and mediastinal disorders2/591/41
DehydrationMetabolism and nutrition disorders2/591/41
DyspneaRespiratory, thoracic and mediastinal disorders2/591/41
FallGeneral disorders2/590/41
HypoxiaRespiratory, thoracic and mediastinal disorders2/590/41
Mucositis oralGastrointestinal disorders2/590/41
Atrial fibrillationCardiac disorders0/591/41
Most frequent other events
Showing 10 of 36
Most frequent other events
EventControl ArmBoost Arm
DysgeusiaNervous system disorders54/5937/41
dry mouthGastrointestinal disorders53/5934/41
DysphagiaGastrointestinal disorders52/5934/41
Mucositis oralGastrointestinal disorders49/5935/41
Dermatitis radiationInjury, poisoning and procedural complications47/5933/41
FatigueGeneral disorders35/5920/41
DehydrationMetabolism and nutrition disorders32/5918/41
Salivary duct inflammationGastrointestinal disorders29/5921/41
EsophagitisGastrointestinal disorders26/5918/41
NauseaGastrointestinal disorders26/5918/41

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Control ArmBoost ArmTotal
<=18 years000
Between 18 and 65 years342660
>=65 years251540
Sex: Female, Male
Sex: Female, Male(Participants)Control ArmBoost ArmTotal
Female5611
Male543589
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Control ArmBoost ArmTotal
Hispanic or Latino000
Not Hispanic or Latino493685
Unknown or Not Reported10515
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Control ArmBoost ArmTotal
American Indian or Alaska Native112
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American112
White453479
More than one race000
Unknown or Not Reported11516
Region of Enrollment
Region of Enrollment(participants)Control ArmBoost ArmTotal
United States5941100
08

Study locations

2 sites
  • Veterans Affairs (VA) Ann Arbor Healthcare System
    Ann Arbor, Michigan 48105, United States
  • University of Michigan Hospital
    Ann Arbor, Michigan 48109, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 1, 2020
  • Informed consent form · Mar 13, 2020

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02031250
Lead sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 9, 2014
Start date
Feb 2014
Primary completion
Feb 22, 2023
Completion
Feb 22, 2023
Results posted
Mar 2, 2026
Last update
Mar 2, 2026

Study contacts

Michelle Mierzwa, M.D.
principal investigator · University of Michigan Rogel Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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