Trial reportInternational journal of radiation oncology, biology, physics2017
Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Accelerated Radiation Plus Cisplatin With or Without Cetuximab for Locally Advanced Head and Neck Carcinoma: NRG Oncology Radiation Therapy Oncology Group 0522.
Trial report in International journal of radiation oncology, biology, physics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00265941 (A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- Patient-Reported Outcomes as Prognostic Indicators for Overall Survival in Cancer: A Systematic Review and Meta-Analysis.JAMA oncology · 2025Pooled it
- A systematic literature review of health state utility values in head and neck cancer.Health and quality of life outcomes · 2017Pooled it
- Phase II trial of individualized/dynamic cisplatin regimens for definitive concurrent chemoradiation therapy in patients with head and neck squamous cell carcinoma.Cancer medicine · 2020Trial
- Trial
- Non-Metastatic Squamous Cell Carcinoma of the Oropharynx: Primary Surgery or (Chemo)radiotherapy?Head & neck · 2026Review
- Long-term outcomes among individuals living with and beyond head and neck cancer: a scoping review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Article
- Patient reported outcomes based on EQ-5D-5L questionnaires in head and neck cancer patients: a real-world study.BMC cancer · 2022Article
- Quality of life score as a prognosticator for pharyngeal cancer patients treated with radiotherapy.Scientific reports · 2022Article
- Article
- Patient-Reported Outcomes after Intensity-Modulated Proton Therapy for Oropharynx Cancer.International journal of particle therapy · 2021Article
- Xerostomia-related quality of life for patients with oropharyngeal carcinoma treated with proton therapy.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2020Article
- Current Prospects of Molecular Therapeutics in Head and Neck Squamous Cell Carcinoma.Pharmaceutical medicine · 2019Review
- Estimating health state utility from activities of daily living in the French National Hospital Discharge Database: a feasibility study with head and neck cancer.Health and quality of life outcomes · 2019Article
- Associations among human papillomavirus, inflammation, and fatigue in patients with head and neck cancer.Cancer · 2018Article
- General health-related quality of life scores from head and neck squamous cell carcinoma patients obtained throughout the first year following diagnosis predicted up to 10-year overall survival.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2018Article
- Prospective observational study of carbon-ion radiotherapy for non-squamous cell carcinoma of the head and neck.Cancer science · 2017Observational
Corrections and comments
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Authors and funding
23 authors at 18 institutions in 2 countries.
Funding
Abstract
purposeTo analyze the quality of life (QOL) and performance status (PS) (secondary outcome) in patients with stage III to IV head and neck cancer (HNC) enrolled on a prospective randomized phase 3 trial comparing radiation-cisplatin without cetuximab (CIS) or with cetuximab (CET/CIS). The QOL hypothesis proposed a between-arm difference in Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) total score of ≥10% of the instrument range from baseline to 1 year. METHODS AND MATERIALS: Patients who gave consent to the QOL/PS study completed the FACT-HN, Performance Status Scale for HNC (PSS-HN), and EuroQol (EQ-5D) at baseline through to 5 years. The pretreatment QOL/PS scores were correlated with outcome and p16 status in patients with oropharyngeal cancer (OPC).
resultsOf 818 analyzable patients, the 1-year change from baseline score for FACT-HN total was -0.41 (CIS arm) and -5.11 (CET/CIS arm) (P=.016), representing a 3.2% between-arm change of the FACT-HN total score. The mean EQ-5D index and PSS-HN scores were not significantly different between arms. The p16-positive OPC patients had significantly higher baseline and 1-year scores for PSS-HN, FACT-HN total, physical and functional subscales, and 2-years for the EQ-5D index compared with p16-negative OPC patients. Higher pretreatment PSS-HN diet, PSS-HN eating, FACT-HN, and EQ-5D index scores were associated with better overall survival (OS) and progression-free (PFS) survival on multivariate analysis. Higher baseline FACT-HN total, functional, physical subscale, and EQ-5D index scores were associated with improved OS and PFS in p16-positive OPC patients but not in p16-negative and non-OPC patients.
conclusionThere was no clinically meaningful difference in QOL/PS between arms. The p16-positive OPC patients had significantly higher QOL/PS than did p16-negative patients. Pretreatment QOL/PS is a significant independent predictor of outcome in locally advanced HNC.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.