Cancer, Head, Cancer Head Neck, Cancer Neck
Conditions
Keywords
MLAP (Machine Learning Adaptive Planning), RapidPlan
Brief summary
The purpose of this study is to determine the magnitude of clinical benefit achieved through machine learning assisted radiation treatment planning (MLAP) on post-treatment clinical outcomes such as acute toxicity and patient reported outcomes.
Detailed description
This is a randomized phase III trial to evaluate the effectiveness of MLAP compared to Standard of Care. Patients will undergo a randomization procedure with a variable allocation ratio where the first third of patients are randomized 3:1 in favor of SOC, the next third randomized 1:1, and the last third randomized 1:3 in favor of MLAP. This is done to give dosimetrists time to optimize the MLAP workflow. Since the treatment team may learn to improve their treatment planning process in the SOC arm through interactions with RapidPlan, as a sensitivity analysis, the primary and secondary goals will be re-analyzed including time of registration as a moderator of the treatment effect.
Interventions
RADIATIONMachine Learning Assisted Radiation (MLAP) RapidPlan
Radiation therapy simulation, target delineation, dosing, localization, and follow-up will be followed per standard of care practices and/or at the discretion of the treating radiation oncologist. To elaborate, patients will receive a treatment planning CT (computed tomography) scan, followed by normal tissue delineation through the physician and/or medical dosimetry assistant, followed by target delineation by the physician, followed by radiation treatment planning with the dosimetrist and medical physicist. The preliminary plan will be run through the RapidPlan module, which will give a list of possible improvements to the plan. The dosimetrist will then make an amendment to the plan according to RapidPlan suggestions, followed by plan change requests and approval by the physician.
RADIATIONRadiation Therapy Standard of Care (SOC)
Radiation therapy simulation, target delineation, dosing, localization, and follow-up will be followed per standard of care practices and/or at the discretion of the treating radiation oncologist. To elaborate, patients will receive a treatment planning CT (computed tomography) scan, followed by normal tissue delineation through the physician and/or medical dosimetry assistant, followed by target delineation by the physician, followed by radiation treatment planning with the dosimetrist and medical physicist, followed by plan change requests and approval by the physician.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years at time of registration * Receiving curative intent intensity modulated radiotherapy for head and neck primary cancer at the discretion of the treating medical doctor (MD) * Provide written informed consent or allow legally authorized representative to consent on behalf of a participant * Willing to return to enrolling institution for study follow-up visit
Exclusion criteria
* Incarcerated * Unable to provide informed consent * Prior Head and Neck (H\&N) radiation therapy * Planned radiation dosing LK\<30 Gy or \>76 Gy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in swallowing score | Baseline (up to 30 days prior to treatment planning); up to 6 months | Will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck module (EORTC QLQ-H\&N35). The EORTC QLQ-H\&N35 is a 35-item questionnaire used to assess symptoms encountered specifically by patients with head and neck cancer. The H\&N35 consists of 7 multiple-item scales (Pain, Swallowing, Senses, Speech, Social eating, Social contact, and Sexuality), in addition to 11 single items (e.g., Opening mouth, Sticky saliva, Dry mouth, etc.). Scores are combined into an overall score ranging from 0=Best to 100=Worst. Swallowing score will be measured at baseline (up to 30 days prior to treatment planning), at the end of Radiation Treatment (+ 14 days), and 3 months post Radiation Treatment (+/-30 days from 3 months post-radiotherapy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in physician-reported toxicities | Baseline; up to 6 months | Assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Toxicities will be recorded at baseline (up to 30 days prior to treatment planning), at the end of Radiation Treatment (+14 days), and 3 months post Radiation Treatment (+/-30 days from 3 months post-radiotherapy). |
| Difference in treatment plan quality metrics (PQMs) across treatment arms | Baseline; up to 6 months | Treatment PQM is a continuous-valued function depending on selected dose-volume histogram statistics for 5 organs-at-risk. Comparisons between treatment arms will be made. |
| Difference in time to complete treatment planning | Baseline; up to 6 months | Treatment planning time is defined as the time in minutes from the end of physician contouring to the end of physician plan approval. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel J. Ma, M.D.
Mayo Clinic in Rochester
Outcome results
None listed