Trial · NCT03822897

De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma

NCT03822897, Phase 2, Active not recruiting, Canadian Cancer Trials Group; results first posted 2025-09-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma. Trials, record NCT03822897. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03822897

On this page

Trial

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

Title: De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma
NCT number: NCT03822897
Status: Active not recruiting
Phases: Phase 2
Enrollment: 103 participants, actual
Lead sponsor: Canadian Cancer Trials Group
Conditions: Oropharyngeal Cancer
Interventions: Radiation, Cisplatin
First posted: 2019-01-30
Last updated: 2026-11-04
Results first posted: 2025-09-30

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Event-free Survival	2 years	Event free survival (EFS) is defined as the time from the date of registration to the date of first record of any of the following events: * Progression. * Surgery. * Non-protocol RT, chemotherapy, or biologic therapy (for the current cancer diagnosis) without documentation of the site of failure. * Death due to any cause. The outcome is reported as the proportion of patients who remain event-free at 2 years.
Secondary	Overall Survival	2 years	For patients who have died, overall survival is calculated in months from the day of registration to date of death. Otherwise, overall survival is censored at the last day the patient is known alive (LKA). The outcome is reported as the proportion of patients who remain alive at 2 years.
Secondary	Local-regional Control	2 years	Local-regional control is defined as the time from the date of registration to the date of any of the following, whichever comes first: * Surgery of primary tumour at any time performed for clinical or radiological disease persistence/progression/recurrence with tumour present/unknown on final pathology. * Neck dissection \> 20 weeks from the end of radiation therapy performed for clinical or radiological (RECIST 1.1) disease persistence/progression/recurrence within target volumes with tumour present/unknown on final pathology. * Neck dissection at any time after registration performed for clinical or radiological disease recurrence/progression outside the target volumes or without documentation of the site of failure with tumour present/unknown on final pathology. * the first record of appearance (radiological or clinical) of local or regional disease progression. The outcome is reported as the proportion of patients who remain local-regional control free at 2 years.
Secondary	Out-of-field Regional Control	2 years	Time to out-of-field regional failure is defined as the time from the date of registration to the date of the first record of appearance of regional progression/recurrence outside the treatment field , or to the date of neck dissection at any time after registration with tumour present/unknown performed for clinical or radiological disease progression outside the target volumes whichever comes first. The outcome is reported as the proportion of patients who remain out-of-field regional control free at 2 years.
Secondary	Distant Metastasis Free Survival	2 years	Distant metastasis free survival is defined as the time from the date of registration to the date of first record of appearance of distant metastasis or death for any cause. Local-regional failure or second cancers diagnosed before the distant metastases are not considered events of interest for this endpoint. Subjects alive and free of distant metastasis are censored at the date of the most recent follow-up examination. The outcome is reported as the proportion of patients who remain distant metastasis event-free at 2 years.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Event-free Survival	2 years	Percentage of patients event-free at 2y	NUMBER
SECONDARY	Overall Survival	2 years	Percentage of patients alive at 2 years	NUMBER
SECONDARY	Local-regional Control	2 years	Percentage of patients LRC free at 2y	NUMBER
SECONDARY	Out-of-field Regional Control	2 years	Percentages of patients ORC free at 2y	NUMBER
SECONDARY	Distant Metastasis Free Survival	2 years	Percentages of patients DMF at 2y	NUMBER

Source ClinicalTrials.gov

Results by group5

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

Outcome	Group	Value	Spread	Units
Event-free Survival	Experimental Arm	91.8	95% Confidence Interval 86.6 to 97.4	Percentage of patients event-free at 2y
Overall Survival	Experimental Arm	94.7	95% Confidence Interval 90.2 to 99.3	Percentage of patients alive at 2 years
Local-regional Control	Experimental Arm	94.8	95% Confidence Interval 90.5 to 99.3	Percentage of patients LRC free at 2y
Out-of-field Regional Control	Experimental Arm	99	95% Confidence Interval 97 to 100	Percentages of patients ORC free at 2y
Distant Metastasis Free Survival	Experimental Arm	91.3	95% Confidence Interval 84.7 to 98.3	Percentages of patients DMF at 2y

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Experimental Arm	103
Overall Study	COMPLETED	Experimental Arm	100
Overall Study	NOT COMPLETED	Experimental Arm	3

Source ClinicalTrials.gov

Adverse events45

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	Ear pain	Ear and labyrinth disorders	Experimental Arm	14	100
other	Hearing impaired	Ear and labyrinth disorders	Experimental Arm	6	100
other	Tinnitus	Ear and labyrinth disorders	Experimental Arm	26	100
other	Constipation	Gastrointestinal disorders	Experimental Arm	39	100
other	Diarrhea	Gastrointestinal disorders	Experimental Arm	6	100
other	Dry mouth	Gastrointestinal disorders	Experimental Arm	94	100
other	Dysphagia	Gastrointestinal disorders	Experimental Arm	49	100
other	Mucositis oral	Gastrointestinal disorders	Experimental Arm	82	100
other	Nausea	Gastrointestinal disorders	Experimental Arm	36	100
other	Oral pain	Gastrointestinal disorders	Experimental Arm	23	100

1 to 10 of 45Source ClinicalTrials.gov

See all 45 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Experimental Arm	6	100
Total, other adverse events	Experimental Arm	100	100
Total, serious adverse events	Experimental Arm	8	100

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/NCT03822897

GET https://conductscience.org/api/trials/v1/NCT03822897/events?page=2

API reference For AI assistants