Trial · NCT02031250

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

NCT02031250, Phase 2, Completed, University of Michigan Rogel Cancer Center; results first posted 2026-03-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer. Trials, record NCT02031250. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02031250

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer
NCT number: NCT02031250
Status: Completed
Phases: Phase 2
Enrollment: 106 participants, actual
Lead sponsor: University of Michigan Rogel Cancer Center
Conditions: Squamous Cell Carcinoma of the Head and Neck
Interventions: Cisplatin, Carboplatin, IMRT (Intensity-Modulated Radiation Therapy), Boost Radiation to Hypoperfused Volumes
First posted: 2014-01-09
Last updated: 2026-03-02
Results first posted: 2026-03-02

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disease Free Survival (DSF) Time- 2 Year Estimate	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.
Secondary	Local-regional Control Rate	2 years post-treatment	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.
Secondary	Proportion of Patients in Which Hypoperfused/Low-diffusion Subvolumes Overlap With Recurrence Volumes	3 years post treatment
Secondary	Percent of Patients With Adverse Events	3 years post treatment	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
Secondary	Correlation Coefficient Between Continuous Dose and Perfusion Summary Measures	2 weeks post Radiation Therapy (RT)	Pearson or Spearman rank based correlation between the continuous dose and perfusion summary measures

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease Free Survival (DSF) Time- 2 Year Estimate	2 years post start of treatment		days	MEDIAN
SECONDARY	Local-regional Control Rate	2 years post-treatment		participants	NUMBER
SECONDARY	Proportion of Patients in Which Hypoperfused/Low-diffusion Subvolumes Overlap With Recurrence Volumes	3 years post treatment		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percent of Patients With Adverse Events	3 years post treatment		Percent of patients	NUMBER
SECONDARY	Correlation Coefficient Between Continuous Dose and Perfusion Summary Measures	2 weeks post Radiation Therapy (RT)	This outcome measure was never analyzed; data was not collected and will never be completed. Data is not available now nor will it be available in the future as the data field was not collected during the study by the original study team and the current study team has no information to analyze.

Source ClinicalTrials.gov

Results by group42

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Disease Free Survival (DSF) Time- 2 Year Estimate	Control Arm		48	90% Confidence Interval 34 to 60	days
Disease Free Survival (DSF) Time- 2 Year Estimate	Boost Arm		57	90% Confidence Interval 43 to 69	days
Local-regional Control Rate	Control Arm		15		participants
Local-regional Control Rate	Boost Arm		7		participants
Proportion of Patients in Which Hypoperfused/Low-diffusion Subvolumes Overlap With Recurrence Volumes	Control Arm		12		Participants
Proportion of Patients in Which Hypoperfused/Low-diffusion Subvolumes Overlap With Recurrence Volumes	Boost Arm		12		Participants
Percent of Patients With Adverse Events	Control Arm	ACUTE TOXICITIES - Hospitalization	21.9		Percent of patients
Percent of Patients With Adverse Events	Boost Arm	ACUTE TOXICITIES - Hospitalization	25.6		Percent of patients
Percent of Patients With Adverse Events	Control Arm	ACUTE TOXICITIES- Interrupted chemotherapy	24.4		Percent of patients
Percent of Patients With Adverse Events	Boost Arm	ACUTE TOXICITIES- Interrupted chemotherapy	23.1		Percent of patients

1 to 10 of 42Source ClinicalTrials.gov

See all 42 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Control Arm	59
Overall Study	STARTED	Boost Arm	41
Overall Study	COMPLETED	Control Arm	54
Overall Study	COMPLETED	Boost Arm	40
Overall Study	NOT COMPLETED	Control Arm	5
Overall Study	NOT COMPLETED	Boost Arm	1

Source ClinicalTrials.gov

Adverse events124

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Blood and lymphatic system disorders	Control Arm	3	59	3
other	Anemia	Blood and lymphatic system disorders	Boost Arm	3	41	7
other	Blood bilirubin increased	Investigations	Control Arm	0	59	0
other	Blood bilirubin increased	Investigations	Boost Arm	2	41	2
other	Chills	General disorders	Control Arm	3	59	3
other	Chills	General disorders	Boost Arm	2	41	2
other	Constipation	Gastrointestinal disorders	Control Arm	9	59	11
other	Constipation	Gastrointestinal disorders	Boost Arm	5	41	5
other	Dehydration	Metabolism and nutrition disorders	Control Arm	32	59	61
other	Dehydration	Metabolism and nutrition disorders	Boost Arm	18	41	30

1 to 10 of 124Source ClinicalTrials.gov

See all 124 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Control Arm	14	59
Total, all-cause mortality	Boost Arm	15	41
Total, other adverse events	Control Arm	59	59
Total, other adverse events	Boost Arm	38	41
Total, serious adverse events	Control Arm	15	59
Total, serious adverse events	Boost Arm	12	41

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01CA184153	Functional imaging-directed adaptive therapy of head and neck cancer	CAO, YUE	UNIVERSITY OF MICHIGAN AT ANN ARBOR	NATIONAL CANCER INSTITUTE	2015 to 2019

Source NIH RePORTER

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Boost Arm vs Control Arm: Local-regional Control Rate	Trial comparisons
Boost Arm vs Control Arm: Proportion of Patients in Which Hypoperfused/Low-diffusion Subvolumes Overlap With Recurrence Volumes	Trial comparisons
Boost Arm vs Control Arm: deaths from any cause	Trial comparisons
Boost Arm vs Control Arm: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02031250

GET https://conductscience.org/api/trials/v1/NCT02031250/results?page=2

API reference For AI assistants