Clinical trial · Interventional
Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning vs Standard Radiation Treatment Planning
A Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning Versus Standard Radiation Treatment Planning
NCT05979883CI-TRIAL-00101603completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Head | Malignant Neoplasm | ALIAS | 0.85 |
| Cancer Head Neck | — | UNRESOLVED | — |
| Cancer Neck | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Machine Learning Assisted Radiation (MLAP) RapidPlan | Radiation | — | UNRESOLVED |
| Radiation Therapy Standard of Care (SOC) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm A: Standard of care (SOC) treatment planning
- description
- Patients randomized to the SOC treatment planning arm will receive a treatment planning computed tomography (CT) scan followed by dosimetric planning with a medical dosimetrist; and the plan will be reviewed by a medical physicist and radiation oncologist. This is the current standard practice for all radiation oncology patients.
- interventionNames
- Radiation: Radiation Therapy Standard of Care (SOC)
- type
- ACTIVE_COMPARATOR
- label
- Arm B: Machine Learning Assisted Planning (MLAP)
- description
- Patients randomized to the MLAP arm will receive a treatment planning scan followed by MLAP through the RapidPlan module produced by Varian. Of note, RapidPlan is an FDA cleared module with treatment planning being the approved usage for the program. The RapidPlan module has site specific treatment packages for different disease sites. These separate disease specific packages have different capabilities. For example, the Head and Neck package currently audits dosimetrist-generated plans for possible improvements. The MLAP arm of the trial will leverage the RapidPlan module's full capabilities upwards to the FDA-approved usage.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.