Trial · NCT01663259

Reduced-intensity Therapy for Oropharyngeal Cancer in Non-smoking HPV-16 Positive Patients

NCT01663259, Not applicable, Completed, University of Michigan Rogel Cancer Center; results first posted 2020-10-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Reduced-intensity Therapy for Oropharyngeal Cancer in Non-smoking HPV-16 Positive Patients. Trials, record NCT01663259. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01663259

On this page

Trial

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

Title: Reduced-intensity Therapy for Oropharyngeal Cancer in Non-smoking HPV-16 Positive Patients
NCT number: NCT01663259
Status: Completed
Phases: Not applicable
Enrollment: 43 participants, actual
Lead sponsor: University of Michigan Rogel Cancer Center
Conditions: Squamous Cell Carcinoma of the Oropharynx, HPV
Interventions: Cetuximab, Radiotherapy
First posted: 2012-08-13
Last updated: 2021-01-19
Results first posted: 2020-10-26

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Rate of Recurrence	2 years	Number of patients whose tumors recur (includes local, regional, and distant recurrence; and second primaries). Note: Research indicates that freedom from local and regional progression (FFLRP) is a more meaningful measure. Therefore, the percentage of patients with FFLRP is included below as a Post-Hoc measure.
Secondary	Number of Participants With Adverse Events	3 years	In order to evaluate the toxicity in patients receiving cetuximab-RT, adverse events were clustered into three categories: None, Mild-Moderate (grade 1 or 2), and Severe (grade 3 or 4). Graded according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4).
Secondary	Treatment Related Toxicities	3 years	Toxicities are measured by number of participants who experience one or more types or indicator of toxicity, shown as all grades and grades 3-4. As each participant could have multiple toxicities, the number of incidents outnumbers the number of participants. Toxicities graded according to the CTCAE v4.
Secondary	Mean Change in Tumor Epidermal Growth Factor Receptor (EGFR)	Day 7	The ratio (fold change) of tumor EGFR post/pre loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.
Secondary	Mean Change in Tumor Phosphorylated EGFR (pEGFR)	Day 7	The ratio (fold change) of tumor pEGFR post/pre loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.
Secondary	Change in Tumor EGFR Level Relative to EGFR in Normal Mucosa	Day 7	Normal mucosa EGFR was assessed for comparison with EGFR in tumor sample. The fold change in tumor EGFR level post/pre loading dose of cetuximab, relative to fold change in normal mucosa EGFR level post/pre loading dose of cetuximab was summarized across all participants who had an evaluable tumor sample and normal mucosa sample. The value reported is the ratio of fold change in tumor/fold change in buccal EGFR.

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Rate of Recurrence	2 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Adverse Events	3 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Treatment Related Toxicities	3 years		participants	NUMBER
SECONDARY	Mean Change in Tumor Epidermal Growth Factor Receptor (EGFR)	Day 7	8 participants had a sample size sufficient for EGFR analysis.	fold change	MEAN
SECONDARY	Mean Change in Tumor Phosphorylated EGFR (pEGFR)	Day 7	2 participants had a sample size sufficient for pEGFR analysis.	fold change	MEAN
SECONDARY	Change in Tumor EGFR Level Relative to EGFR in Normal Mucosa	Day 7	7 participants had a sample size sufficient for EGFR analysis.	ratio	MEAN
POST_HOC	Disease Free Survival Rate	2 years		Percentage of participants	NUMBER
POST_HOC	Overall Survival Rate	2 years		Percentage of participants	NUMBER
POST_HOC	Freedom From Local Regional Progression (FFLRP)	2 years		percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group21

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

Outcome	Group	Category	Value	Units
Rate of Recurrence	Cetuximab + Radiotherapy		8	Participants
Number of Participants With Adverse Events	Cetuximab + Radiotherapy	None	0	Participants
Number of Participants With Adverse Events	Cetuximab + Radiotherapy	Mild-Moderate	14	Participants
Number of Participants With Adverse Events	Cetuximab + Radiotherapy	Severe	28	Participants
Treatment Related Toxicities	Cetuximab + Radiotherapy	All Grades : Cutaneous Toxicity	38	participants
Treatment Related Toxicities	Cetuximab + Radiotherapy	All Grades : Mucositis	42	participants
Treatment Related Toxicities	Cetuximab + Radiotherapy	All Grades : Dysphagia	37	participants
Treatment Related Toxicities	Cetuximab + Radiotherapy	All Grades : Hematologic Toxicity	13	participants
Treatment Related Toxicities	Cetuximab + Radiotherapy	Grades 3-4 : Cutaneous Toxicity	3	participants
Treatment Related Toxicities	Cetuximab + Radiotherapy	Grades 3-4 : Mucositis	19	participants

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Cetuximab + Radiotherapy	42
Overall Study	COMPLETED	Cetuximab + Radiotherapy	42
Overall Study	NOT COMPLETED	Cetuximab + Radiotherapy	0

Source ClinicalTrials.gov

Adverse events115

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	Cetuximab	5	42	5
other	Lymph node pain	Blood and lymphatic system disorders	Cetuximab	1	42	1
other	Sinus tachycardia	Cardiac disorders	Cetuximab	3	42	5
other	External ear inflammation	Ear and labyrinth disorders	Cetuximab	1	42	1
other	Abdominal pain	Gastrointestinal disorders	Cetuximab	1	42	1
other	Constipation	Gastrointestinal disorders	Cetuximab	9	42	9
other	Diarrhea	Gastrointestinal disorders	Cetuximab	4	42	6
other	Dry mouth	Gastrointestinal disorders	Cetuximab	40	42	92
other	Dyspepsia	Gastrointestinal disorders	Cetuximab	1	42	1
other	Dysphagia	Gastrointestinal disorders	Cetuximab	40	42	96

1 to 10 of 115Source ClinicalTrials.gov

See all 115 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cetuximab	2	42
Total, other adverse events	Cetuximab	42	42
Total, serious adverse events	Cetuximab	9	42

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

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

None in this release.

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/NCT01663259

GET https://conductscience.org/api/trials/v1/NCT01663259/results?page=2

API reference For AI assistants