Clinical trial NCT04359199: QUantitative Assessment of Swallowing After Radiation (QUASAR)
Official title: QUantitative Assessment of Swallowing After Radiation (QUASAR): A Longitudinal Comparison of Swallowing Function by Systemic Therapy in Head and Neck Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer
Dysphagia
Oropharyngeal Dysphagia
Oropharynx Cancer
Oropharynx Squamous Cell Carcinoma
Keywords: head and neck cancer
oropharyngeal dysphagia
radiation therapy
immunotherapy
videofluoroscopic swallow study
modified barium swallow study
oropharynx cancer
oropharynx squamous cell carcinoma
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with head and neck carcinoma treated with definitive radiation therapy and systemic therapy (chemotherapy or immunotherapy) in the University of California San Diego Healthcare System will be eligible.

Brief summary: 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).

Detailed description: The QUASAR study will use a prospective, observational, cross sectional design (See Schema). HNC patients treated with definitive RT and immunotherapy or chemotherapy (cetuximab or cisplatin) will undergo VFSS at 4-6 and 12-24 months post-treatment. Patients enrolled prior to 6 months after finishing therapy will undergo a swallow study during the 4-6 month period AND the 12-24 month period. Patients enrolled after 6 months after finishing therapy will undergo a single swallow study in the 12-24 month period. The primary endpoint of PCR at 12-24 months will be compared between patients treated with immunotherapy versus chemotherapy.

All patients with HNC treated with definitive RT and systemic therapy at our institution will be eligible. In particular, we will recruit patients for this study from participants in two ongoing trials investigating the use of concurrent immunotherapy. The KEYCHAIN trial (ClinicalTrials.gov Identifier: NCT03383094) randomizes patients with locally advanced p16+ HNC undergoing definitive RT to concurrent q3 week cisplatin versus concurrent and adjuvant pembrolizumab. NRG-HN004 (ClinicalTrials.gov Identifier: NCT03258554) is a cooperative group trial that compares HNC patients that are not eligible for cisplatin undergoing definitive radiation therapy to concurrent cetuximab versus durvalumab.

Eligibility criteria: 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

Primary outcomes:
measure: Swallowing function 12-24 months after concurrent radiation and systemic therapy for HNC, as measured by the PCR
timeFrame: 12-24 months
Secondary outcomes:
measure: Quantitative swallowing function at 4-6 months and 12-24 months by PCR, TPT, PRR and PPWT
timeFrame: 4-6 months and 12-24 months
measure: Correlation between quantitative swallowing function and patient reported symptoms using the EAT-10 tool
timeFrame: 12-24 months
measure: Correlation between radiation dose and location of swallowing function and quantitative swallowing function
timeFrame: 24 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Loren K Mell, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Leonard 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.
citation: Servagi-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.
citation: Jensen 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.
citation: Duprez F, Madani I, De Potter B, Boterberg T, De Neve W. Systematic review of dose--volume correlates for structures related to late swallowing disturbances after radiotherapy for head and neck cancer. Dysphagia. 2013 Sep;28(3):337-49. doi: 10.1007/s00455-013-9452-2. Epub 2013 Feb 22.
citation: Liang Y, Messer K, Rose BS, Lewis JH, Jiang SB, Yashar CM, Mundt AJ, Mell LK. Impact of bone marrow radiation dose on acute hematologic toxicity in cervical cancer: principal component analysis on high dimensional data. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):912-9. doi: 10.1016/j.ijrobp.2009.11.062. Epub 2010 May 14.
citation: Green G, Kim E, Carmona R, Shen H, Murphy JD, Mell LK. Incidence of Long-Term Esophageal Dilation With Various Treatment Approaches in the Older Head and Neck Cancer Population. Front Oncol. 2018 Oct 23;8:466. doi: 10.3389/fonc.2018.00466. eCollection 2018.