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Trial · NCT04116047

CompARE: Escalating Treatment of Intermediate and High-risk Oropharyngeal Cancer (OPC)

NCT04116047, Phase 3, Active not recruiting, University of Birmingham

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. CompARE: Escalating Treatment of Intermediate and High-risk Oropharyngeal Cancer (OPC). Trials, record NCT04116047. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04116047

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Trial

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

Title
CompARE: Escalating Treatment of Intermediate and High-risk Oropharyngeal Cancer (OPC)
NCT number
NCT04116047
Status
Active not recruiting
Phases
Phase 3
Enrollment
785 participants, estimated
Lead sponsor
University of Birmingham
Conditions
Oropharyngeal Cancer
Interventions
Cisplatin, Durvalumab, Radiotherapy
First posted
2019-10-04
Last updated
2026-05-07
Other registries' IDs
eudract:2014-003389-26, isrctn:ISRCTN41478539

Source ClinicalTrials.gov

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryPatient Overall survival (OS)from randomisation until date of death from any cause (follow-up until 8 years post-treatment)defined as the interval in whole days between date of randomisation and date of death from any cause
PrimaryPatient Event Free Survival (EFS)From randomisation until date of progression/persistence/recurrence/death (follow-up until 8 years post-treatment)defined as the interval in whole days between date of randomisation until date of progression/persistence/recurrence/death
SecondaryNumber of Acute (<3 months post-treatment) toxicity events experiencedFrom date of randomisation until 2 year follow-up
Total number of acute (\<3 months post-treatment) severe (grade 3-5) toxicity events experienced. Adverse events will be collected post-treatment and graded according to Common Terminology Criteria for Adverse Events (CTCAE).
SecondaryNumber of late (up to 2 years post-treatment) toxicity events experienced using CTCAEFrom date of randomisation until 2 year follow-up
Severe (grade 3-5) adverse events will be collected up to 2 years post randomisation, these events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and version 3.0 for scoring mucositis.
SecondaryNumber of late (up to 2 years post-treatment) toxicity events experienced using RTOGFrom date of randomisation until 2 year follow-upLate and severe toxicity events at 2 years post randomisation,will be collected and graded using Radiation Therapy Oncology Group (RTOG) Radiation Morbidity Scoring Criteria
SecondaryHead and neck specific quality of life at 2 years post-randomisation using EORTC C30From date of randomisation until 2 year follow-up
Patients will complete the European Organisation for Research and Treatment of Cancer (EORTC) C30 questionnaire at baseline, at the end of treatment, and during the follow-up period until 2 years post-treatment
SecondaryHead and neck specific Quality of Life at 2 years post-randomisationFrom date of randomisation until 2 year follow-up
Patients will complete the European Organisation for Research and Treatment of Cancer (EORTC) H\&N35 questionnaire at baseline, at the end of treatment, and during the follow-up period until 2 years post-treatment
SecondarySwallowing outcomes assessed using MDADI Questionnaire at 24 months post-chemoradiotherapyFrom date of randomisation until 2 year follow-upPatients will complete the M.D. Anderson Dysphagia Inventory (MDADI) Questionnaire at baseline, at the end of treatment, and during the follow-up period until 2 years post-treatment
SecondaryLevels of Percutaneous Endoscopic Gastrostomy (PEG) useFrom date of randomisation until 2 year follow-upPEG use will be assessed at baseline, throughout treatment and during 2 year follow-up period
SecondaryCost effectiveness of treatment as assessed using EuroQol Group (EQ-5D) questionnaireFrom date of randomisation until 2 year follow-upPatients will complete the EuroQol Group (EQ-5D) questionnaire at baseline, at the end of treatment, and during the follow-up period until 2 years post-treatment

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/NCT04116047

GET https://conductscience.org/api/trials/v1/NCT04116047/registered