QUantitative Assessment of Swallowing After Radiation (QUASAR)

Loren Mell, MD

Status

Enrolling

Conditions

Oropharynx Cancer

Dysphagia

Oropharyngeal Dysphagia

Oropharynx Squamous Cell Carcinoma

Head and Neck Cancer

Treatments

Radiation: Radiation Therapy

Drug: Cetuximab

Drug: Chemotherapy

Drug: Immunotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT04359199

190048

Details and patient eligibility

About

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).

Full 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.

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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