Trial · NCT03416153

Individualized Adaptive De-escalated Radiotherapy for HPV-related Oropharynx Cancer

NCT03416153, Phase 2, Completed, University of Michigan Rogel Cancer Center; results first posted 2025-05-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Individualized Adaptive De-escalated Radiotherapy for HPV-related Oropharynx Cancer. Trials, record NCT03416153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03416153

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Trial

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

Title: Individualized Adaptive De-escalated Radiotherapy for HPV-related Oropharynx Cancer
NCT number: NCT03416153
Status: Completed
Phases: Phase 2
Enrollment: 91 participants, actual
Lead sponsor: University of Michigan Rogel Cancer Center
Conditions: Oropharynx Cancer
Interventions: Carboplatin, Radiation Therapy, Paclitaxel
First posted: 2018-01-30
Last updated: 2026-08-07
Results first posted: 2025-05-22

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	The Percentage of Patients With Local Regional Recurrence (LRR) of Disease	1 Year	RECIST (Response Evaluation Criteria In Solid Tumors) will be used to evaluate response and recurrence. All patients will be analyzed together as the goal of the study is to estimate risk of LRR in this patient population treated with this particular strategy in which some patients continue to receive standard therapy while others are de-escalated. Results will also be estimated and reported separately for patients receiving standard or de-escalated therapy.
Primary	Change in Metabolic Tumor Volume 50% (MTV 50%)	2 months	The change in metabolic tumor volume (MTV)50% at the mid-treatment timepoint will be calculated as percent change from baseline and used as a continuous variable in a Cox model for an outcome of time to LRR. Will also evaluate more non-parametrically, the relation between hazard of LRR and mid-treatment MTV50% using a kernel estimator in a Cox model.
Secondary	Patterns of Failure	at 3 months and 2 years	Kaplan-Meier estimate of the percentage of participants who experienced Locoregional relapse versus distant relapse
Secondary	Overall Survival	at 3 months, and 2 Years	Kaplan-Meier estimate of the percentage of participants who are still alive at 3 months and 2 years.
Secondary	Progression- Free Survival	at 3 months and 2 years	Kaplan-Meier estimate of the percentage of participants who are still in progression free survival at 3 months and 2 years
Secondary	Incidence of Toxicity	1, 3 and 12 months	Toxicity outcomes will be estimated as proportions of patients with available toxicity data at 1, 3 and 12 months. XQ, Xerostomia Questionnaire, is scored on a scale of 0-100 with higher score indicating worse xerostomia. HN, FACT-HN, is scored on a scale of 0-190 with higher score indicating a better quality of life.
Secondary	Detectable Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Participants	from Baseline up to 7 weeks	Median values of ctDNA molecules present throughout the study. The week 6/7 measurement is taken as the first measurement that was available during weeks 6 and 7 to minimize missing data and to account for minor timing deviations in sample collection during weeks 6 and 7
Other	Quality of Life Assessed Per the Functional Assessment of Cancer Therapy-Head and Neck (FACTHN)	2 Years	Quality of life (QOL) outcomes and swallowing study results will be summarized descriptively by timepoint. If there is substantial missingness in the QOL outcomes the study will assess for informative missingness by comparing earlier QOL scores and change in earlier QOL scores between patients missing QOL at later time points (e.g. 1 or 2 years).

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Percentage of Patients With Local Regional Recurrence (LRR) of Disease	1 Year		percentage of participants	NUMBER
PRIMARY	Change in Metabolic Tumor Volume 50% (MTV 50%)	2 months	2 patients were not evaluable	percent change from baseline	MEAN
SECONDARY	Quality of Life Assessed Per the Functional Assessment of Cancer Therapy-Head and Neck (FACTHN)	2 Years
SECONDARY	The Proportion of Patients Alive	2 Years
SECONDARY	Incidence of Toxicity	3, 6, 12 and 24 Months
SECONDARY	Detectable Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Participants	4 weeks

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
The Percentage of Patients With Local Regional Recurrence (LRR) of Disease	Standard Treatment	2	95% Confidence Interval 0 to 6	percentage of participants
The Percentage of Patients With Local Regional Recurrence (LRR) of Disease	De-escalation Treatment	3	95% Confidence Interval 0 to 8	percentage of participants
Change in Metabolic Tumor Volume 50% (MTV 50%)	Standard Treatment	-11.3	Standard Deviation 66.7	percent change from baseline
Change in Metabolic Tumor Volume 50% (MTV 50%)	De-escalation Treatment	-71.1	Standard Deviation 16.7	percent change from baseline

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Standard Treatment	49
Overall Study	STARTED	De-escalation Treatment	36
Overall Study	COMPLETED	Standard Treatment	47
Overall Study	COMPLETED	De-escalation Treatment	35
Overall Study	NOT COMPLETED	Standard Treatment	2
Overall Study	NOT COMPLETED	De-escalation Treatment	1

Source ClinicalTrials.gov

Adverse events90

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	Abdominal pain	General disorders	Standard Treatment	4	49	4
other	Abdominal pain	General disorders	De-escalation Treatment	0	36	0
other	Alanine aminotransferase increased	Investigations	Standard Treatment	5	49	5
other	Alanine aminotransferase increased	Investigations	De-escalation Treatment	0	36	0
other	Anemia	Investigations	Standard Treatment	4	49	5
other	Anemia	Investigations	De-escalation Treatment	0	36	0
other	Anorexia	Psychiatric disorders	Standard Treatment	7	49	7
other	Anorexia	Psychiatric disorders	De-escalation Treatment	0	36	0
other	Anxiety	Psychiatric disorders	Standard Treatment	8	49	8
other	Anxiety	Psychiatric disorders	De-escalation Treatment	0	36	0

1 to 10 of 90Source ClinicalTrials.gov

See all 90 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard Treatment	2	49
Total, all-cause mortality	De-escalation Treatment	1	36
Total, other adverse events	Standard Treatment	49	49
Total, other adverse events	De-escalation Treatment	36	36
Total, serious adverse events	Standard Treatment	5	49
Total, serious adverse events	De-escalation Treatment	3	36

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
U01CA183848	Quantitative MRI models of HN Cancers for Physiological Adaption of RT	CAO, YUE	UNIVERSITY OF MICHIGAN AT ANN ARBOR	NATIONAL CANCER INSTITUTE	2014 to 2019

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
Standard Treatment vs De-escalation Treatment: deaths from any cause	Trial comparisons
Standard Treatment vs De-escalation Treatment: 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/NCT03416153

GET https://conductscience.org/api/trials/v1/NCT03416153/events?page=2

API reference For AI assistants