Clinical trial · Observational
QUantitative Assessment of Swallowing After Radiation (QUASAR)
QUantitative Assessment of Swallowing After Radiation (QUASAR): A Longitudinal Comparison of Swallowing Function by Systemic Therapy in Head and Neck Cancer Patients
NCT04359199CI-TRIAL-00063828QUASARunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To use novel methods for quantitative analysis of VFSS (videofluoroscopic swallow study, also known as modified barium swallow) to study and compare dysphagia in patients treated for head and neck carcinoma with concurrent radiation therapy and chemotherapy (cisplatin) or targeted therapy (cetuximab) vs. immunotherapy (pembrolizumab, nivolumab, or durvalumab). Our hypothesis is that pharyngeal constriction will be greater (lower ratio) with concurrent immunotherapy compared to chemotherapy, as measured by the pharyngeal constriction ratio (PCR).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysphagia | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oropharyngeal Dysphagia | — | UNRESOLVED | — |
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
| Oropharynx Squamous Cell Carcinoma | Oropharynx Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Immunotherapy | Drug | Immunotherapy | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Radiotherapy with chemotherapy
- description
- Patients treated with definitive RT and chemotherapy (cisplatin) or targeted therapy (cetuximab)
- interventionNames
- Radiation: Radiation Therapy
- Drug: Cetuximab
- Drug: Chemotherapy
- label
- Radiotherapy with immunotherapy
- description
- Patients treated with definitive RT and immunotherapy (pembrolizumab, nivolumab, or durvalumab)
- interventionNames
- Radiation: Radiation Therapy
- Drug: Immunotherapy
Primary outcomes (1)
- measure
- Swallowing function 12-24 months after concurrent radiation and systemic therapy for HNC, as measured by the PCR
- timeFrame
- 12-24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-proven, un-resected invasive carcinoma of the head and neck. * Treated with definitive RT and concurrent systemic therapy or treated within the past 4-24 months * Concurrent systemic therapy with Cisplatin, Cetuximab or immunotherapy. * Age ≥ 18 * Able to understand and willing to sign a written informed consent. Exclusion Criteria: * Prior radiotherapy that would result in overlap of planned radiation therapy fields. * Prior systemic chemotherapy, unless as part of the coordinated plan of care for the treatment of the carcinoma (e.g., induction/neoadjuvant chemotherapy is allowed) * Planned adjuvant (i.e., following definitive chemoradiotherapy) chemotherapy or surgery
References
Publications (11)
- BACKGROUNDNaidoo J, Page DB, Li BT, Connell LC, Schindler K, Lacouture ME, Postow MA, Wolchok JD. Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. Ann Oncol. 2015 Dec;26(12):2375-91. doi: 10.1093/annonc/mdv383. Epub 2015 Sep 14. PMID 26371282
- BACKGROUNDBasch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, Scher HI, Schrag D. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol. 2006 Nov;7(11):903-9. doi: 10.1016/S1470-2045(06)70910-X. PMID 17081915
- BACKGROUNDLeonard R, Kendall K. Dysphagia Assessment and Treatment Planning: A Team Approach. Fourth. Plural Publishing; 2018
- BACKGROUNDStoeckli SJ, Huisman TA, Seifert B, Martin-Harris BJ. Interrater reliability of videofluoroscopic swallow evaluation. Dysphagia. 2003 Winter;18(1):53-7. doi: 10.1007/s00455-002-0085-0. PMID 12497197
- BACKGROUNDYip H, Leonard R, Belafsky PC. Can a fluoroscopic estimation of pharyngeal constriction predict aspiration? Otolaryngol Head Neck Surg. 2006 Aug;135(2):215-7. doi: 10.1016/j.otohns.2006.03.016. PMID 16890070
- BACKGROUNDLeonard R, Rees CJ, Belafsky P, Allen J. Fluoroscopic surrogate for pharyngeal strength: the pharyngeal constriction ratio (PCR). Dysphagia. 2011 Mar;26(1):13-7. doi: 10.1007/s00455-009-9258-4. Epub 2009 Oct 24. PMID 19856026
- BACKGROUNDServagi-Vernat S, Ali D, Roubieu C, Durdux C, Laccourreye O, Giraud P. Dysphagia after radiotherapy: state of the art and prevention. Eur Ann Otorhinolaryngol Head Neck Dis. 2015 Feb;132(1):25-9. doi: 10.1016/j.anorl.2013.09.006. Epub 2014 Jun 9. PMID 24924114
- BACKGROUNDJensen K, Lambertsen K, Grau C. Late swallowing dysfunction and dysphagia after radiotherapy for pharynx cancer: frequency, intensity and correlation with dose and volume parameters. Radiother Oncol. 2007 Oct;85(1):74-82. doi: 10.1016/j.radonc.2007.06.004. Epub 2007 Jul 27.