Trial Outcomes & Findings for DMH-Based Plan Evaluation and Inverse Optimization in Radiotherapy (NCT NCT02663817)

Last Updated: 2020-02-05

Results Overview

The study is computational in nature. A new treatment planning paradigm is proposed, where from the newly proposed treatment plans, and the treatment plans generated with the standard of care, radiation doses to different organs and tissues would be derived. Radiotherapy toxicity (to healthy human tissue) is proportional to radiation dose - more radiation dose results in higher toxicity. Thereby, if radiation dose is decreased, the toxicity would also be decreased. The dosimetric differences which the investigators observe between the standard of care and their novel optimization approach are reported as percent change with respect to the standard of care.

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

Baseline, up to three years.

Results posted on

2020-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	IMRT Study participants being treated according to the standard of care with intensity modulated radiotherapy (IMRT). Several CT scans will be performed for each enrolled subject: one before the radiotherapy course for patient treatment planning purposes (as part of the standard of care), one during the radiotherapy treatment course (between fraction 10 and 20), and one at follow up visit or at least 6 weeks post-radiotherapy treatment (whichever comes first).
Overall Study STARTED	52
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	IMRT Study participants being treated according to the standard of care with intensity modulated radiotherapy (IMRT). Several CT scans will be performed for each enrolled subject: one before the radiotherapy course for patient treatment planning purposes (as part of the standard of care), one during the radiotherapy treatment course (between fraction 10 and 20), and one at follow up visit or at least 6 weeks post-radiotherapy treatment (whichever comes first).
Overall Study Screen failure	2

Baseline Characteristics

DMH-Based Plan Evaluation and Inverse Optimization in Radiotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMRT n=52 Participants Study participants being treated according to the standard of care with intensity modulated radiotherapy (IMRT). Several CT scans will be performed for each enrolled subject: one before the radiotherapy course for patient treatment planning purposes (as part of the standard of care), one during the radiotherapy treatment course (between fraction 10 and 20), and one at follow up visit or at least 6 weeks post-radiotherapy treatment (whichever comes first).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Disease site Head and neck	27 Participants n=5 Participants
Disease site Prostate	9 Participants n=5 Participants
Disease site Lung	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, up to three years.

Population: Two participants with prostate cancer were screen failures.

Outcome measures

Outcome measures
Measure	IMRT Lung n=16 Participants Study participants being treated according to the standard of care with intensity modulated radiotherapy (IMRT) for Lung cancer.	IMRT Prostate n=7 Participants Study participants being treated according to the standard of care with intensity modulated radiotherapy (IMRT) for Prostate cancer.	IMRT Head and Neck n=27 Participants Study participants being treated according to the standard of care with intensity modulated radiotherapy (IMRT) for Head-and-Neck cancer.
Percent Change in Radiation Dose to Healthy Human Tissue. Dmh - Esophagus	25.0 Percent change in radiation dose Interval -2.6 to 61.0	—	—
Percent Change in Radiation Dose to Healthy Human Tissue. Dmh - Lungs	2.0 Percent change in radiation dose Interval -3.0 to 6.0	—	—
Percent Change in Radiation Dose to Healthy Human Tissue. Energy - Heart	11.0 Percent change in radiation dose Interval 0.1 to 44.7	—	—
Percent Change in Radiation Dose to Healthy Human Tissue. Energy - Spinal Cord	24.0 Percent change in radiation dose Interval -8.0 to 63.0	—	7.0 Percent change in radiation dose Interval -5.0 to 27.0
Percent Change in Radiation Dose to Healthy Human Tissue. Energy - Esophagus	16.0 Percent change in radiation dose Interval -2.6 to 39.7	—	—
Percent Change in Radiation Dose to Healthy Human Tissue. Energy - Lungs	10.0 Percent change in radiation dose Interval -3.0 to 21.0	—	—
Percent Change in Radiation Dose to Healthy Human Tissue. Energy for HN - Brainstem	—	—	11.0 Percent change in radiation dose Interval -5.0 to 34.1
Percent Change in Radiation Dose to Healthy Human Tissue. Energy for HN - Larynx	—	—	9.0 Percent change in radiation dose Interval -7.0 to 21.0
Percent Change in Radiation Dose to Healthy Human Tissue. Energy for HN - Lt Parotid	—	—	14.0 Percent change in radiation dose Interval -17.0 to 38.0
Percent Change in Radiation Dose to Healthy Human Tissue. Energy for HN - Rt Parotid	—	—	13.0 Percent change in radiation dose Interval -7.0 to 38.5
Percent Change in Radiation Dose to Healthy Human Tissue. Energy Prostate - Bladder D15	—	2.0 Percent change in radiation dose Interval -2.6 to 10.6	—
Percent Change in Radiation Dose to Healthy Human Tissue. Energy Prostate - Bladder D25	—	6.5 Percent change in radiation dose Interval -5.5 to 30.0	—
Percent Change in Radiation Dose to Healthy Human Tissue. Energy Prostate - Rectum D15	—	1.7 Percent change in radiation dose Interval -6.0 to 9.7	—
Percent Change in Radiation Dose to Healthy Human Tissue. Energy Prostate - Rectum D25	—	5.0 Percent change in radiation dose Interval -1.2 to 11.5	—
Percent Change in Radiation Dose to Healthy Human Tissue. Dmh - Heart	3.0 Percent change in radiation dose Interval -4.9 to 8.0	—	—
Percent Change in Radiation Dose to Healthy Human Tissue. Dmh - Spinal Cord	31.0 Percent change in radiation dose Interval -8.0 to 67.0	—	—
Percent Change in Radiation Dose to Healthy Human Tissue. Energy Prostate - Rt Femur D10	—	32.5 Percent change in radiation dose Interval -0.8 to 71.0	—
Percent Change in Radiation Dose to Healthy Human Tissue. Energy Prostate - Lt Femur D10	—	32.7 Percent change in radiation dose Interval -0.6 to 78.0	—

Adverse Events

IMRT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ivaylo Mihaylov

University of Miami

Phone: 305-243-8223

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place