N/A
Completed N=52
DMH-Based Plan Evaluation and Inverse Optimization in Radiotherapy
Source: ClinicalTrials.gov NCT02663817 ↗Enrolled (actual)
52
Serious AEs
—
Results posted
Feb 2020
Primary outcomePrimary: Percent Change in Radiation Dose to Healthy Human Tissue. — 3.0; 31.0; 25.0; 2.0 Percent change in radiation dose
Summary
The hypotheses of the study are as follows:
* Mass-based inverse optimization in radiotherapy treatment planning will result in a reduction of normal tissue and organs at risk (OAR) doses for desired prescription therapeutic doses to the targets.
* Dose-mass histograms (DMHs) may be more relevant to radiotherapy treatment planning and treatment plan assessment than the standard of care, realized through dose-volume histograms (DVHs)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Radiation Dose to Healthy Human Tissue. |
3.0; 31.0; 25.0; 2.0; 11.0; 24.0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically confirmed head-and-neck, lung, or prostate tumors.
- Patients who will be treated with radiation therapy or concurrent chemoradiation therapy.
- Gross Tumor Volume (GTV) or resection cavity must be visible on CT such that it can be delineated as a target for radiotherapy.
- Patients who are able to understand the investigational nature of this study and agree to sign a written informed consent document.
Exclusion Criteria
- Pregnant or nursing women will not participate. Women of reproductive potential must be offered a pre-treatment pregnancy test and informed of the need to practice an effective contraceptive method during the therapy.
- Patients younger than 18 years.
- Patients whose size and weight would not allow CT scanning.
- No vulnerable populations (fetuses, pregnant women, children, prisoners) will be included in this study.
Data sourced from ClinicalTrials.gov (NCT02663817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.