Trial · NCT02908477

Evaluation of De-escalated Adjuvant Radiation Therapy for Human Papillomavirus (HPV)-Associated Oropharynx Cancer

NCT02908477, Phase 3, Completed, Mayo Clinic; results first posted 2024-04-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of De-escalated Adjuvant Radiation Therapy for Human Papillomavirus (HPV)-Associated Oropharynx Cancer. Trials, record NCT02908477. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02908477

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Trial

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

Title: Evaluation of De-escalated Adjuvant Radiation Therapy for Human Papillomavirus (HPV)-Associated Oropharynx Cancer
NCT number: NCT02908477
Status: Completed
Phases: Phase 3
Enrollment: 228 participants, actual
Lead sponsor: Mayo Clinic
Conditions: Oropharynx Cancer
Interventions: Adjuvant Radiation Therapy, Docetaxel, Cisplatin
First posted: 2016-09-21
Last updated: 2025-02-11
Results first posted: 2024-04-08

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Grade 3+ Adverse Events Rate	2 years	To compare rate of late grade 3-5 toxicities between de-escalated adjuvant radiation therapy (DART) and standard adjuvant therapy.
Secondary	Local/Regional Control	2 years	Local/regional failure percentage as assessed by imaging or physical exam at 2 years after study registration for patients treated with DART vs standard therapy.
Secondary	Quality of Life Between DART and Standard Adjuvant Therapy - FACT-HN	1 year	To compare the overall QOL between DART and standard adjuvant therapy at 1-year post-treatment as measured by the Functional Assessment of Cancer Therapy - Head \& Neck (FACT-HN) questionnaire. The FACT-HN consists of 12 questions related to symptoms and feeling over the past 7 days. Items are answered on a scale of 0-4 where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.
Secondary	Quality of Life Between DART and Standard Adjuvant Therapy - EORTC-QLQ-HN35	1 year	To compare the overall QOL between DART and standard adjuvant therapy at 1-year post-treatment as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Head and Neck Module (EORTC-QLQ-HN35). The questionnaire consists of 35 items related to symptoms or problems during the past week. Thirty (30) items are answered on a scale of 0-4 where 0=not at all; 1=a little; 3=quite a bit, and 4=very much, and five (5) items are answered with yes/no.
Secondary	Overall Survival	2 years	Percentage of patients alive at 2 years.
Secondary	Disease-free Survival	2 years	Percentage of patients disease free and alive at 2 years.
Secondary	Distant Failure Associated With DART vs Standard Treatment	2 years	Distant failure is defined as cancer that has recurred or spread to a part of the body far away from the original tumor site

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Grade 3+ Adverse Events Rate	2 years	All treated patients	events per participant	NUMBER
SECONDARY	Local/Regional Control	2 years		percentage of participants	NUMBER
SECONDARY	Quality of Life Between DART and Standard Adjuvant Therapy - FACT-HN	1 year
SECONDARY	Quality of Life Between DART and Standard Adjuvant Therapy - EORTC-QLQ-HN35	1 year
SECONDARY	Overall Survival	2 years		percentage of participants	NUMBER
SECONDARY	Disease-free Survival	2 years		percentage of participants	NUMBER
SECONDARY	Distant Failure Associated With DART vs Standard Treatment	2 years

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Units
Grade 3+ Adverse Events Rate	De-escalated Adjuvant Radiation Therapy (DART)	.032	events per participant
Grade 3+ Adverse Events Rate	Standard of Care Treatment (SOC)	.115	events per participant
Local/Regional Control	De-escalated Adjuvant Radiation Therapy (DART)	95.9	percentage of participants
Local/Regional Control	Standard of Care Treatment (SOC)	98.3	percentage of participants
Overall Survival	De-escalated Adjuvant Radiation Therapy (DART)	96.9	percentage of participants
Overall Survival	Standard of Care Treatment (SOC)	98.3	percentage of participants
Disease-free Survival	De-escalated Adjuvant Radiation Therapy (DART)	88.2	percentage of participants
Disease-free Survival	Standard of Care Treatment (SOC)	96.6	percentage of participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	De-escalated Adjuvant Radiation Therapy (DART)	136
Overall Study	STARTED	Standard of Care Treatment (SOC)	92
Overall Study	COMPLETED	De-escalated Adjuvant Radiation Therapy (DART)	128
Overall Study	COMPLETED	Standard of Care Treatment (SOC)	64
Overall Study	NOT COMPLETED	De-escalated Adjuvant Radiation Therapy (DART)	8
Overall Study	NOT COMPLETED	Standard of Care Treatment (SOC)	28

Source ClinicalTrials.gov

Adverse events80

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	Accessory nerve disorder	Nervous system disorders	De-escalated Adjuvant Radiation Therapy (DART)	27	136	27
other	Accessory nerve disorder	Nervous system disorders	Standard of Care Treatment (SOC)	13	92	13
other	Alopecia	Skin and subcutaneous tissue disorders	De-escalated Adjuvant Radiation Therapy (DART)	25	136	25
other	Alopecia	Skin and subcutaneous tissue disorders	Standard of Care Treatment (SOC)	17	92	17
other	Anxiety	Psychiatric disorders	De-escalated Adjuvant Radiation Therapy (DART)	31	136	31
other	Anxiety	Psychiatric disorders	Standard of Care Treatment (SOC)	20	92	20
other	Aspiration	Respiratory, thoracic and mediastinal disorders	De-escalated Adjuvant Radiation Therapy (DART)	12	136	12
other	Aspiration	Respiratory, thoracic and mediastinal disorders	Standard of Care Treatment (SOC)	6	92	6
other	Brachial plexopathy	Nervous system disorders	De-escalated Adjuvant Radiation Therapy (DART)	10	136	10
other	Brachial plexopathy	Nervous system disorders	Standard of Care Treatment (SOC)	5	92	5

1 to 10 of 80Source ClinicalTrials.gov

See all 80 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	De-escalated Adjuvant Radiation Therapy (DART)	2	136
Total, all-cause mortality	Standard of Care Treatment (SOC)	9	92
Total, other adverse events	De-escalated Adjuvant Radiation Therapy (DART)	128	136
Total, other adverse events	Standard of Care Treatment (SOC)	60	92
Total, serious adverse events	De-escalated Adjuvant Radiation Therapy (DART)	0	136
Total, serious adverse events	Standard of Care Treatment (SOC)	1	92

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
40402484	DERIVED	PubMed
40907518	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons2

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

Comparison	Source
De-escalated Adjuvant Radiation Therapy (DART) vs Standard of Care Treatment (SOC): deaths from any cause	Trial comparisons
De-escalated Adjuvant Radiation Therapy (DART) vs Standard of Care Treatment (SOC): 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/NCT02908477

GET https://conductscience.org/api/trials/v1/NCT02908477/events?page=2

API reference For AI assistants