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

NCT ID: NCT05849142

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Oropharynx Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

MRIdian Linac

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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ViewRay

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Stuart Samuels

Associate Professor of Clinical Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stuart Samuels, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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The University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20220776

Identifier Type: -

Identifier Source: org_study_id

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