Feasibility of Adaptive Radiation Therapy for Human-papilloma Virus-positive Oropharyngeal Cancer Patients on MRIdian Linac (OPC-V)

The purpose of this research is to determine whether it is feasible to treat patients with Human Papilloma Virus positive (HPV-positive) oropharyngeal tumors on a specialized treatment machine (MRIdian linear accelerator [Linac]), which utilizes magnetic resonance imaging (MRI) for radiation planning and delivery.

Study Overview

• Status: Not yet recruiting
• Conditions: Oropharynx Cancer
• Intervention / Treatment: Device: MRIdian Linac

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amit Jethanandani, MD; Phone Number: 3052435470; Email: axj812@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • The University of Miami Sylvester Comprehensive Cancer Center
      • Principal Investigator: Stuart Samuels, MD, PhD
      • Contact: Stuart Samuels, MD, PhD; Phone Number: 305-243-5470; Email: ssamuels@miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pathologically confirmed new diagnosis of HPV-positive OPC [i.e. Base of tongue, tonsil, soft palate, vallecula, and posterior pharyngeal wall]
• American Joint Committee on Cancer (AJCC) 8th edition Stage I-III planned for definitive chemoradiation.
• Members of all races and ethnic backgrounds
• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for duration of study participation.
• Must be able to understand and sign an Institutional Review Board (IRB)-approved written informed consent document.

Exclusion Criteria:

• Prior surgery, chemotherapy, or radiation treatment for head and neck cancer
• Prior history of cancer other than non-melanomatous skin cancer
• Distant metastases (cM1) or (pM1) disease)
• Evidence of a compromised airway
• Medical contraindications to MRIs
• Unable to tolerate MRIs without sedation
• Pregnant patients
• Breastfeeding patients
• Eastern Cooperative Oncology Group (ECOG) performance status >1

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRIdian Linac Group; All accrued participants will be enrolled onto the MRIdian Linac Group. Participants will receive adaptive radiotherapy (ART) on the MRIdian Linac. Participants will complete the duration of their radiotherapy regimen on the MRIdian Linac for approximately 7 weeks.	Device: MRIdian Linac; Radiation therapy (RT) will be delivered with an integrated MRI-RT delivery system (MRIdian Linac). Participants will then receive standard-of-care RT with a dose prescription of 70 Gy in 35 fractions on the MRIdian Linac. Adaptive RT (ART) planning will occur every 5th fraction of RT.; Other Names: ViewRay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent difference between initial reference plan and adaptive weekly RT plan	Weekly adaptive plans will be compared to the initial reference plan and compared using a percent difference equation estimating the actual values of the quantities used as dosimetric constraints for each participant between the initial reference plan and the weekly adaptive plan[s].	Up to 6 months
Evaluation of deformable imaging registration	For evaluation of deformable imaging registration, deformed contours will be compared to the physician-segmented contours using the Dice similarity coefficient (DSC).	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment times recorded in minutes	We will follow previously-established guidelines by the MR-Linac Consortium Head and Neck Tumor Site for measuring treatment times. Treatment times will be calculated in minutes from the time stamps in the record and verify system. Three timepoints will be recorded: [1] setup and plan optimization [i.e. time between the participant's arrival to the MRidian and delivery of the first beam]; [2] beam delivery [i.e. the time between delivery of the first and last beam]; and [3] total treatment time.	Up to 6 months
Patient-reported Quality of Life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30)	Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). It consists of 30 items to measure multiple aspects that incorporated five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale, and six single common items (dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties). The scoring system ranged from 1 (not at all) to 4 (very much). High scores for functional items and low scores for symptoms represent the good QoL.There are two questions for the overall quality of life rating, and the ranking ranged from 1 (very poor) to 7 (excellent).	Up to 1 year
Patient-reported Quality of Life as measured by the European Organization for Research and Treatment Head & Neck 43	Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-H&N43). The questionnaire used will be for that for head and neck patients, score range from 1 (not at all) to 4 (very much), higher scores indicate lower quality of life.	Up to 1 year

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Stuart Samuels, MD, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neoplasms, Squamous Cell; Oropharyngeal Neoplasms; Papilloma
• Other Study ID Numbers: 20220776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No