Trial · NCT07888816

Optimizing Response to Immunotherapy With Online Adaptive Pulsed Radiotherapy in Incurable Head and Neck Cancers

NCT07888816, Phase 2, Not yet recruiting, University Health Network, Toronto

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Optimizing Response to Immunotherapy With Online Adaptive Pulsed Radiotherapy in Incurable Head and Neck Cancers. Trials, record NCT07888816. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07888816

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Trial

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

Title: Optimizing Response to Immunotherapy With Online Adaptive Pulsed Radiotherapy in Incurable Head and Neck Cancers
NCT number: NCT07888816
Status: Not yet recruiting
Phases: Phase 2
Enrollment: 48 participants, estimated
Lead sponsor: University Health Network, Toronto
Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)
Interventions: Pulsed Adaptive Radiotherapy Combined with Pembrolizumab with or without chemotherapy
First posted: 2026-10-22
Last updated: 2026-10-22

Source ClinicalTrials.gov

Registered outcomes14

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

List	Outcome	Time frame	Description
Primary	12-Month Progression-Free Survival	12 months	12-month progression-free survival will be estimated using the Kaplan-Meier method. The proportion of patients progression-free at 12 months will be compared to the historical benchmark of 17%. The study will be considered positive if the lower bound of the 95% confidence interval exceeds 17%.
Secondary	12-Month Modified Progression-Free Survival (mPFS)	12 months	Modified progression-free survival is defined as the time from study enrollment to disease progression that is no longer amenable to local salvage radiotherapy or death from any cause, whichever occurs first.
Secondary	Treatment-Related Adverse Events	12 Months	The incidence, severity, and type of acute and late treatment-related adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0.
Secondary	Changes in Patient-Reported Quality of Life	12 Months	Assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) with higher scores indicating better quality of life. Changes from baseline will be assessed at each study time point.
Secondary	Changes in Patient-Reported Quality of Life and Functional Outcomes	12 Months	Assessed using the EORTC Head and Neck Cancer Module (QLQ-H\&N43). Scores range from 0 to 100 scale where for the functional scales, higher scores indicate better functioning. For symptom scales and symptom items, higher scores indicate greater symptom burden or worse symptoms. Changes from baseline over the study period will be evaluated.
Secondary	Swallowing Function	12 Months	Swallowing function will be assessed using the Functional Oral Intake Scale (FOIS), where scores range from 1 to 7, where 1 indicates no oral intake (nothing by mouth) and 7 indicates a full oral diet with no restrictions. Higher scores indicate better oral intake and swallowing function. Changes from baseline over the study period will be evaluated.
Secondary	Changes in Patient-Reported Quality of Life and Functional Outcomes	12 Months	Assessed using the Performance Status Scale for Head and Neck Cancer (PSS-HN), which evaluates three domains: Normalcy of Diet, Eating in Public, and Understandability of Speech. Each domain is scored separately on a scale from 0 to 100, with higher scores indicating better function and less impairment. Changes from baseline over the study period will be evaluated.
Secondary	Median Progression-Free Survival (PFS)	12 months	Estimated using the Kaplan-Meier method with 95% confidence intervals
Secondary	Median Overall Survival (OS)	12 months	Estimated using the Kaplan-Meier method with 95% confidence intervals
Secondary	Objective Response Rate (ORR)	12 months	Reported as a proportion with 95% confidence intervals

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes0

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

None in this release.

Results by group0

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

None in this release.

Participant flow0

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

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

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/NCT07888816

GET https://conductscience.org/api/trials/v1/NCT07888816/registered

API reference For AI assistants