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

University of Miami

Status: Withdrawn

Conditions: Oropharynx Cancer

Treatments: Device: MRIdian Linac

Study type: Interventional

Funder types: Other

Identifiers

NCT05849142

20220776

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

MRIdian Linac Group

Experimental group

Description:

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.

Treatment:

Device: MRIdian Linac