Trial · NCT01687413

Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer

NCT01687413, Phase 3, Terminated, Washington University School of Medicine; results first posted 2020-11-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer. Trials, record NCT01687413. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01687413

On this page

Trial

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

Title: Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer
NCT number: NCT01687413
Status: Terminated
Phases: Phase 3
Enrollment: 42 participants, actual
Lead sponsor: Washington University School of Medicine
Conditions: Oropharyngeal Neoplasms
Interventions: Intensity-modulated radiation therapy (IMRT), Cisplatin
First posted: 2012-09-18
Last updated: 2020-11-25
Results first posted: 2020-11-10

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Disease-free Survival (DFS)	1 year
Primary	Locoregional Control	Up to 2 years	Rate of patients with no recurrence at original oropharyngeal site or in the neck nodal basins.
Secondary	Rate of Distant Metastasis	Up to 2 years	Assessed by biopsy or imaging-detected recurrent disease at sites away from the original primary and cervical zone.
Secondary	Disease Specific Survival	1 year
Secondary	Number of Complications/Acute Toxicity by Organ Class	Approximately 18 weeks	-Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Secondary	Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory	Baseline, 1 month, 6 months, 12 months, and 24 months	* Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). Strongly agree = 1, Disagree = 2, No opinion = 3, Agree = 4, and Strongly Agree = 5 * The lower the score the lower the quality of life
Secondary	Change in Cognitive Function as Measured by Cognitive Failures Questionnaire	Baseline, 1 month, 12 months, and 24 months	* 25 questions to assess the frequency in which participants experience cognitive failures including forgetfulness, distractibility, and false triggering * Answers range from 0 = never to 4 = very often * The higher the score the worse the cognitive failures the participant has experienced
Secondary	Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII)	Baseline, 12 months, and 24 months	-The NDII consists of 10 questions; each with a 5 level ordinally scaled response option ranging from "not at all" to "a lot". The response for each item is then scored from 1 to 5, with 5 denoting higher quality of life (Not at all) and 1 being the least (A lot).
Secondary	Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire	Baseline, 1 month, 6 months, 12 months, and 24 months	* It contains 8 questions regarding dryness either during feeding or in the unstimulated state. Participants rate each item from 0 to 10, where 10 indicates the maximum dryness or discomfort due to dryness. * The higher the score the worse the participant's xerostomia
Secondary	Change in Hearing as Measured by Hearing Handicap Inventory - Adult	Baseline, 1 month, and 12 months	* 11 item questionnaire to identify issues with hearing * Answers are yes = 4, sometimes = 2, and no = 0 * The higher the score the more issues the participant has with hearing

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Disease-free Survival (DFS)	1 year		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Locoregional Control	Up to 2 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Rate of Distant Metastasis	Up to 2 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Disease Specific Survival	1 year		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Complications/Acute Toxicity by Organ Class	Approximately 18 weeks	One participant in each Arm did not have adverse events collected.	number of adverse events	NUMBER
SECONDARY	Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory	Baseline, 1 month, 6 months, 12 months, and 24 months	Some participants were not analyzed as the participants did not complete the questionnaires.	score on a scale	MEAN
SECONDARY	Change in Cognitive Function as Measured by Cognitive Failures Questionnaire	Baseline, 1 month, 12 months, and 24 months	Some participants were not analyzed as the participants did not complete the questionnaires.	score on a scale	MEAN
SECONDARY	Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII)	Baseline, 12 months, and 24 months	Some participants were not analyzed as the participants did not complete the questionnaires.	score on a scale	MEAN
SECONDARY	Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire	Baseline, 1 month, 6 months, 12 months, and 24 months	Some participants were not analyzed as the participants did not complete the questionnaires.	score on a scale	MEAN
SECONDARY	Change in Hearing as Measured by Hearing Handicap Inventory - Adult	Baseline, 1 month, and 12 months	Some participants were not analyzed as the participants did not complete the questionnaires.	score on a scale	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group1,004

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

Outcome	Group	Category	Value	Units
Number of Participants With Disease-free Survival (DFS)	Radiotherapy		24	Participants
Number of Participants With Disease-free Survival (DFS)	Radiotherapy, Cisplatin		10	Participants
Locoregional Control	Radiotherapy		26	Participants
Locoregional Control	Radiotherapy, Cisplatin		9	Participants
Rate of Distant Metastasis	Radiotherapy		2	Participants
Rate of Distant Metastasis	Radiotherapy, Cisplatin		0	Participants
Disease Specific Survival	Radiotherapy		24	Participants
Disease Specific Survival	Radiotherapy, Cisplatin		10	Participants
Number of Complications/Acute Toxicity by Organ Class	Radiotherapy	Blood and lymphatic system disorders	5	number of adverse events
Number of Complications/Acute Toxicity by Organ Class	Radiotherapy, Cisplatin	Blood and lymphatic system disorders	12	number of adverse events

1 to 10 of 1,004Source ClinicalTrials.gov

See all 1,004 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Radiotherapy	27
Overall Study	STARTED	Radiotherapy, Cisplatin	15
Overall Study	COMPLETED	Radiotherapy	26
Overall Study	COMPLETED	Radiotherapy, Cisplatin	11
Overall Study	NOT COMPLETED	Radiotherapy	1
Overall Study	NOT COMPLETED	Radiotherapy, Cisplatin	4

Source ClinicalTrials.gov

Adverse events176

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
other	Anemia	Blood and lymphatic system disorders	Radiotherapy	2	27
other	Anemia	Blood and lymphatic system disorders	Radiotherapy, Cisplatin	9	11
other	Febrile neutropenia	Blood and lymphatic system disorders	Radiotherapy	0	27
other	Febrile neutropenia	Blood and lymphatic system disorders	Radiotherapy, Cisplatin	1	11
other	Atrial fibrillation	Cardiac disorders	Radiotherapy	0	27
other	Atrial fibrillation	Cardiac disorders	Radiotherapy, Cisplatin	1	11
other	Ear pain	Ear and labyrinth disorders	Radiotherapy	2	27
other	Ear pain	Ear and labyrinth disorders	Radiotherapy, Cisplatin	0	11
other	Hearing impaired	Ear and labyrinth disorders	Radiotherapy	1	27
other	Hearing impaired	Ear and labyrinth disorders	Radiotherapy, Cisplatin	1	11

1 to 10 of 176Source ClinicalTrials.gov

See all 176 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Radiotherapy	1	27
Total, all-cause mortality	Radiotherapy, Cisplatin	0	11
Total, other adverse events	Radiotherapy	26	27
Total, other adverse events	Radiotherapy, Cisplatin	10	11
Total, serious adverse events	Radiotherapy	0	27
Total, serious adverse events	Radiotherapy, Cisplatin	1	11

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25057165	DERIVED

Source 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 comparisons6

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

Comparison	Source
Radiotherapy vs Radiotherapy, Cisplatin: Rate of Distant Metastasis	Trial comparisons
Radiotherapy vs Radiotherapy, Cisplatin: Number of Participants With Disease-free Survival (DFS)	Trial comparisons
Radiotherapy vs Radiotherapy, Cisplatin: Locoregional Control	Trial comparisons
Radiotherapy vs Radiotherapy, Cisplatin: Disease Specific Survival	Trial comparisons
Radiotherapy vs Radiotherapy, Cisplatin: deaths from any cause	Trial comparisons
Radiotherapy vs Radiotherapy, Cisplatin: 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/NCT01687413

GET https://conductscience.org/api/trials/v1/NCT01687413/results?page=2

API reference For AI assistants