Trial · NCT04116047
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient 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 |
| Primary | Patient 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 |
| Secondary | Number of Acute (<3 months post-treatment) toxicity events experienced | From 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). |
| Secondary | Number of late (up to 2 years post-treatment) toxicity events experienced using CTCAE | From 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. |
| Secondary | Number of late (up to 2 years post-treatment) toxicity events experienced using RTOG | From date of randomisation until 2 year follow-up | Late and severe toxicity events at 2 years post randomisation,will be collected and graded using Radiation Therapy Oncology Group (RTOG) Radiation Morbidity Scoring Criteria |
| Secondary | Head and neck specific quality of life at 2 years post-randomisation using EORTC C30 | From 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 |
| Secondary | Head and neck specific Quality of Life at 2 years post-randomisation | From 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 |
| Secondary | Swallowing outcomes assessed using MDADI Questionnaire at 24 months post-chemoradiotherapy | From date of randomisation until 2 year follow-up | Patients 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 |
| Secondary | Levels of Percutaneous Endoscopic Gastrostomy (PEG) use | From date of randomisation until 2 year follow-up | PEG use will be assessed at baseline, throughout treatment and during 2 year follow-up period |
| Secondary | Cost effectiveness of treatment as assessed using EuroQol Group (EQ-5D) questionnaire | From date of randomisation until 2 year follow-up | Patients 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 |
| Secondary | Surgical complication rates in each arm for patients who require a neck dissection at 4 months following the 3 month post-chemoradiotherapy assessment scan. | At 4 months following the 3 month post-chemoradiotherapy scan | Surgical complication rates will be assessed at trial visits if a neck dissection is required at 4 months post-chemotherapy |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT04116047/registered