Back to resultsFeasibility of Adaptive Radiation Therapy for Human-papilloma Virus-positive Oropharyngeal Cancer Patients on MRIdian Linac (OPC-V)
Primary Purpose
Oropharynx Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRIdian Linac
Sponsored by
About this trial
This is an interventional treatment trial for Oropharynx Cancer
Eligibility Criteria
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
Sites / Locations
- The University of Miami Sylvester Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRIdian Linac Group
Arm 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.
Outcomes
Primary Outcome Measures
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].
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).
Secondary Outcome Measures
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.
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05849142
Brief Title
Feasibility of Adaptive Radiation Therapy for Human-papilloma Virus-positive Oropharyngeal Cancer Patients on MRIdian Linac
Acronym
OPC-V
Official Title
Feasibility of Adaptive Radiation Therapy for Human-papilloma Virus-positive Oropharyngeal Cancer Patients on MRIdian Linac
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharynx Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MRIdian Linac Group
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
MRIdian Linac
Other Intervention Name(s)
ViewRay
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent difference between initial reference plan and adaptive weekly RT plan
Description
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].
Time Frame
Up to 6 months
Title
Evaluation of deformable imaging registration
Description
For evaluation of deformable imaging registration, deformed contours will be compared to the physician-segmented contours using the Dice similarity coefficient (DSC).
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Treatment times recorded in minutes
Description
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.
Time Frame
Up to 6 months
Title
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)
Description
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).
Time Frame
Up to 1 year
Title
Patient-reported Quality of Life as measured by the European Organization for Research and Treatment Head & Neck 43
Description
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.
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amit Jethanandani, MD
Phone
3052435470
Email
axj812@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Samuels, MD, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Miami Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart Samuels, MD, PhD
Phone
305-243-5470
Email
ssamuels@miami.edu
First Name & Middle Initial & Last Name & Degree
Stuart Samuels, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility of Adaptive Radiation Therapy for Human-papilloma Virus-positive Oropharyngeal Cancer Patients on MRIdian Linac
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