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

Oropharynx Cancer Clinical Trial

— OPC-V  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05849142
• Other study ID #: 20220776
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: University of Miami
• Contact: Amit Jethanandani, MD
• Phone: 3052435470
• Email: axj812[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oropharyngeal Neoplasms
• Oropharynx Cancer
• Papilloma

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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