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

NCT05849142 | Withdrawn FDA Device

• 1 other identifier: 20220776
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oropharynx Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Treatment times recorded in minutes

  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)

  Up to 1 year

• Patient-reported Quality of Life as measured by the European Organization for Research and Treatment Head & Neck 43

  Up to 1 year

Study Arms (1)

MRIdian Linac Group

EXPERIMENTAL

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

Interventions

MRIdian Linac DEVICE

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.

Also known as: ViewRay

MRIdian Linac Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

The University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Stuart Samuels, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 8, 2023
• Study Start: December 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)