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QUantitative Assessment of Swallowing After Radiation (QUASAR) (QUASAR)

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ClinicalTrials.gov Identifier: NCT04359199
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Loren Mell, MD, University of California, San Diego

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).


Condition or disease Intervention/treatment
Head and Neck Cancer Dysphagia Oropharyngeal Dysphagia Oropharynx Cancer Oropharynx Squamous Cell Carcinoma Radiation: Radiation Therapy Drug: Cetuximab Drug: Chemotherapy Drug: Immunotherapy

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.

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Study Type : Observational
Estimated Enrollment : 42 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: QUantitative Assessment of Swallowing After Radiation (QUASAR): A Longitudinal Comparison of Swallowing Function by Systemic Therapy in Head and Neck Cancer Patients
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2023

Group/Cohort Intervention/treatment
Radiotherapy with chemotherapy
Patients treated with definitive RT and chemotherapy (cisplatin) or targeted therapy (cetuximab)
Radiation: Radiation Therapy
Routine radiation dosing (approximately 70 Gy in 35 fractions over 6.5 weeks) to the head and neck for the treatment of head and neck cancer
Other Names:
  • radiotherapy
  • RT

Drug: Cetuximab
Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor used for the treatment of head and neck cancer
Other Name: Erbitux

Drug: Chemotherapy
Cisplatin is a chemotherapy medication used to treat a number of cancers, including head and neck cancer
Other Name: Cisplatin

Radiotherapy with immunotherapy
Patients treated with definitive RT and immunotherapy (pembrolizumab, nivolumab, or durvalumab)
Radiation: Radiation Therapy
Routine radiation dosing (approximately 70 Gy in 35 fractions over 6.5 weeks) to the head and neck for the treatment of head and neck cancer
Other Names:
  • radiotherapy
  • RT

Drug: Immunotherapy

Keytruda or Pembrolizumab is a highly selective humanized monoclonal IgG4 antibody directed against the PD-1 receptor on the cell surface.

Opdivo or Nivolumab is a targeted therapy. It is a human programmed death receptor-1 (PD-1) blocking antibody.

Imfinzi or Durvalumab is an anti-cancer ("antineoplastic") drug. This medication is classified as an Anti-PD-L1 monoclonal antibody.

Other Names:
  • pembrolizumab
  • Keytruda
  • nivolumab
  • Opdivo
  • durvalumab
  • Imfinzi




Primary Outcome Measures :
  1. Swallowing function 12-24 months after concurrent radiation and systemic therapy for HNC, as measured by the PCR [ Time Frame: 12-24 months ]
    will use a two-sample t-test at 0.05 level to compare Pharyngeal Constriction Ratio (PCR) between groups


Secondary Outcome Measures :
  1. Quantitative swallowing function at 4-6 months and 12-24 months by PCR, TPT, PRR and PPWT [ Time Frame: 4-6 months and 12-24 months ]

    To compare swallowing function between systemic therapies with additional quantitative metrics of swallowing dysfunction from the VFSS including TPT, PRR and PPWT.

    The presence of aspiration or strictures on VFSS will be compared as binary variables between groups using Pearson's Chi squared test.


  2. Correlation between quantitative swallowing function and patient reported symptoms using the EAT-10 tool [ Time Frame: 12-24 months ]

    To compare patient reported assessments of swallowing function with the EAT-10 tool between systemic therapies.

    To test if there is correlation between the quantitative VFSS metrics and patient reported outcomes on the EAT-10 index, we will calculate Pearson's correlation coefficient and plot the results on a correlation matrix. The Holm step down procedure will be used to adjust for multiple testing to control the family-wise error rate at 0.05 level.


  3. Correlation between radiation dose and location of swallowing function and quantitative swallowing function [ Time Frame: 24 months ]

    The purpose of this aim is to evaluate the effect of radiation dose on swallowing structures, applying a previously developed space-preserving NTCP approach based on principal component analysis (PCA).

    Using this approach, dose distributions to the global swallowing apparatus (i.e. pharynx, larynx and esophagus) will be standardized for patients from both arms of Aim 1, using deformable registration to standardize organs and 3-D dose distributions to a common template. Dose distributions will be converted into a dose array and PCA will be applied to the dose array, as previously described. We will then use PC linear regression to identify eigenvectors significantly associated with long term dysphagia (as measured by PCR).




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359199


Contacts
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Contact: Khusbu Singh, MBBS, CCRP 858-245-2604 ksingh@health.ucsd.edu
Contact: Gerald Henderson 858-534-4811 gehenderson@health.ucsd.edu

Locations
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United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Khushbu Singh, MBBS, CCRP    858-246-2604      
Principal Investigator: Loren Mell, MD         
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Gerald Henderson, BA    858-822-5223    gehenderson@ucsd.edu   
Sponsors and Collaborators
Loren Mell, MD
Investigators
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Principal Investigator: Loren K Mell, MD University of California, San Diego
Publications of Results:
Other Publications:
Leonard R, Kendall K. Dysphagia Assessment and Treatment Planning: A Team Approach. Fourth. Plural Publishing; 2018

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Responsible Party: Loren Mell, MD, Director, Division of Clinical and Translational Research/ Department of Radiation Medicine and Applied Sciences, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04359199    
Other Study ID Numbers: 190048
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Loren Mell, MD, University of California, San Diego:
head and neck cancer
oropharyngeal dysphagia
radiation therapy
immunotherapy
videofluoroscopic swallow study
modified barium swallow study
oropharynx cancer
oropharynx squamous cell carcinoma
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Deglutition Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Stomatognathic Diseases
Cisplatin
Pembrolizumab
Nivolumab
Cetuximab
Durvalumab
Antineoplastic Agents
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action