Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
Loren K Mell, MD
Photo of Loren K Mell
Loren K Mell

Description

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).

Official Title

QUantitative Assessment of Swallowing After Radiation (QUASAR): A Longitudinal Comparison of Swallowing Function by Systemic Therapy in Head and Neck Cancer Patients

Details

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.

Keywords

Head and Neck Cancer Dysphagia Oropharyngeal Dysphagia Oropharynx Cancer Oropharynx Squamous Cell Carcinoma radiation therapy immunotherapy videofluoroscopic swallow study modified barium swallow study Carcinoma, Squamous Cell Head and Neck Neoplasms Oropharyngeal Neoplasms Deglutition Disorders Cisplatin Pembrolizumab Nivolumab Cetuximab Durvalumab Chemotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Locations

  • UC San Diego Moores Cancer Center
    La Jolla California 92093 United States
  • UCSD Moores Cancer Center
    La Jolla California 92093 United States

Lead Scientist at UCSD

  • Loren K Mell, MD
    Professor, Radiation Medicine and Applied Science. Authored (or co-authored) 137 research publications. Research interests: Personalized Medicine · Clinical Trials · Risk Modeling · Immune System · Imaging · Immunotherapy.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Loren Mell, MD
ID
NCT04359199
Study Type
Observational
Last Updated