QUantitative Assessment of Swallowing After Radiation (QUASAR)

NCT04359199 | Unknown

• 1 other identifier: 190048
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 2

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).

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

Outcome Measures

Primary Outcomes (1)

• Swallowing function 12-24 months after concurrent radiation and systemic therapy for HNC, as measured by the PCR

  will use a two-sample t-test at 0.05 level to compare Pharyngeal Constriction Ratio (PCR) between groups

  12-24 months

Secondary Outcomes (3)

• Quantitative swallowing function at 4-6 months and 12-24 months by PCR, TPT, PRR and PPWT

  4-6 months and 12-24 months

• Correlation between quantitative swallowing function and patient reported symptoms using the EAT-10 tool

  12-24 months

• Correlation between radiation dose and location of swallowing function and quantitative swallowing function

  24 months

Study Arms (2)

Radiotherapy with chemotherapy

Patients treated with definitive RT and chemotherapy (cisplatin) or targeted therapy (cetuximab)

Radiation: Radiation Therapy; Drug: Cetuximab; Drug: Chemotherapy

Radiotherapy with immunotherapy

Patients treated with definitive RT and immunotherapy (pembrolizumab, nivolumab, or durvalumab)

Radiation: Radiation Therapy; Drug: Immunotherapy

Interventions

Radiation Therapy RADIATION

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

Also known as: radiotherapy, RT

Radiotherapy with chemotherapy; Radiotherapy with immunotherapy

Cetuximab DRUG

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

Also known as: Erbitux

Radiotherapy with chemotherapy

Chemotherapy DRUG

Cisplatin is a chemotherapy medication used to treat a number of cancers, including head and neck cancer

Also known as: Cisplatin

Radiotherapy with chemotherapy

Immunotherapy DRUG

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.

Also known as: pembrolizumab, Keytruda, nivolumab, Opdivo, durvalumab, Imfinzi

Radiotherapy with immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Loren Mell, MD: lead

Study Sites (2)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

Related Publications (11)

• Naidoo 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 BACKGROUND

• Basch 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 BACKGROUND

• Leonard R, Kendall K. Dysphagia Assessment and Treatment Planning: A Team Approach. Fourth. Plural Publishing; 2018

  BACKGROUND

• Stoeckli 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 BACKGROUND

• Yip 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 BACKGROUND

• 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.

  PMID: 19856026 BACKGROUND

• 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.

  PMID: 24924114 BACKGROUND

• 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.

  PMID: 17673322 BACKGROUND

• 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.

  PMID: 23429941 BACKGROUND

• 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.

  PMID: 20472344 BACKGROUND

• 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.

  PMID: 30406032 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Deglutition Disorders; Oropharyngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Radiotherapy; Cetuximab; Drug Therapy; Cisplatin; Immunotherapy; pembrolizumab; Nivolumab; durvalumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Stomatognathic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Immunomodulation; Biological Therapy

Study Officials

• Loren K Mell, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khusbu Singh, MBBS, CCRP

CONTACT

858-245-2604; ksingh@health.ucsd.edu

Gerald Henderson

CONTACT

858-534-4811; gehenderson@health.ucsd.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Division of Clinical and Translational Research/ Department of Radiation Medicine and Applied Sciences

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 24, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

US (2)