Trial Outcomes & Findings for Proton Therapy for Hodgkin Lymphoma (NCT NCT00850200)

NCT ID: NCT00850200

Last Updated: 2019-01-31

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Immediately proceeding completion of each of the three treatment plans
• Results posted on: 2019-01-31

Participant Flow

Participant milestones

Measure	Optimal Treatment Plan Each patient has three radiation treatment plans conducted prior to initiation of treatment (proton, IMRT, conventional). Only the plan that's found to be the most optimal in regard to minimizing the heart v4 is the one that was actually used to treat the patient. In this case, the proton plan was found to be the optimal plan in each case; patients were therefore treated with proton therapy between 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV). The primary endpoint of this study is the paired differences among the three plans. Thus there's just one treatment arm.
Overall Study STARTED	20
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Optimal Treatment Plan Each patient has three radiation treatment plans conducted prior to initiation of treatment (proton, IMRT, conventional). Only the plan that's found to be the most optimal in regard to minimizing the heart v4 is the one that was actually used to treat the patient. In this case, the proton plan was found to be the optimal plan in each case; patients were therefore treated with proton therapy between 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV). The primary endpoint of this study is the paired differences among the three plans. Thus there's just one treatment arm.
Overall Study Physician Decision	2
Overall Study Did not recieve treatment	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Proton Therapy for Hodgkin Lymphoma

Baseline characteristics by cohort

Measure	Proton Therapy Plan Compared to IMRT and Conventional RT n=19 Participants Each patient has a proton, IMRT and conventional plan done prior to treatment for dosimetric comparison of the primary endpoint which is the percent of the body that receives 4 Gray (%V4). The plan that delivers the smallest %V4 will be the plan that is pursued for actual treatment. Therefore, each patient will have three treatment plans, but will only be treated with one of these three plans (the superior one).
Age, Categorical <=18 years	5 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	24.5 years FULL_RANGE 13.5 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately proceeding completion of each of the three treatment plans

Outcome measures

Measure	Proton Radiation Plan n=19 Participants Proton Radiation Plan: Between 21-39.6 Gy/CGE to the PTV	Conventional Photon Radiation Plan n=19 Participants Conventional Photon Radiation Plan: Between 21-39.6 Gy/CGE to the PTV	Intensity Modulated Radiation Plan n=19 Participants Intensity Modulated Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
Comparison of Normal Tissue Exposed to Greater Than or Equal to 4 Gy/CGE With Use of Proton Therapy Compared to Both Intensity Modulated Radiotherapy (IMRT) and Conventional Therapy.	0.161 percentage of body receiving 4 Gy Interval 0.062 to 0.346	0.291 percentage of body receiving 4 Gy Interval 0.162 to 0.497	0.355 percentage of body receiving 4 Gy Interval 0.189 to 0.811

SECONDARY outcome

Timeframe: 4 years after beginning of radiation therapy

Population: Patients treated with the optimal dosimetric modality

Overall survival as assessed with the Kaplan-Meier product limit method.

Outcome measures

Measure	Proton Radiation Plan n=15 Participants Proton Radiation Plan: Between 21-39.6 Gy/CGE to the PTV	Conventional Photon Radiation Plan Conventional Photon Radiation Plan: Between 21-39.6 Gy/CGE to the PTV	Intensity Modulated Radiation Plan Intensity Modulated Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
Percentage of Participants Who Survived	92 percentage of participants Interval 61.0 to 99.0	—	—

SECONDARY outcome

Timeframe: 4 years after beginning of radiation therapy

Population: Patients treated with the optimal dosimetric modality

Disease free survival as assessed with the Kaplan-Meier product limit method

Outcome measures

Measure	Proton Radiation Plan n=15 Participants Proton Radiation Plan: Between 21-39.6 Gy/CGE to the PTV	Conventional Photon Radiation Plan Conventional Photon Radiation Plan: Between 21-39.6 Gy/CGE to the PTV	Intensity Modulated Radiation Plan Intensity Modulated Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
Percentage of Participants Who Did Not Have Disease Progression	93 percentage of participants Interval 63.0 to 99.0	—	—

Adverse Events

Superior Treatment Plan

Serious events: 0 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Superior Treatment Plan n=15 participants at risk Each patient has three radiation treatment plans conducted prior to initiation of treatment (proton, IMRT, conventional). Only the plan that's found to be the most optimal in regard to minimizing the heart v4 is the one that was actually used to treat the patient. In this case, the proton plan was found to be the optimal plan in each case; patients were therefore treated with proton therapy between 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV). The primary endpoint of this study is the paired differences among the three plans. Thus there's just one treatment arm.
Gastrointestinal disorders Dyspepsia - acute grade 2	20.0% 3/15 • Number of events 3 • Cumulative adverse events were collected via regular 6 month patient follow-ups after the completion of treatment. There were 20 patients initially enrolled. One decided to not receive treatment after initial enrollment. Three had treatment plans completed (and thus contributed that data), but sought treatment elsewhere. One patient was withdrawn after treatment. There are therefore only 15 of 20 enrolled patients actually assessable for adverse events.
Gastrointestinal disorders Esophagitis - acute grade 2	20.0% 3/15 • Number of events 3 • Cumulative adverse events were collected via regular 6 month patient follow-ups after the completion of treatment. There were 20 patients initially enrolled. One decided to not receive treatment after initial enrollment. Three had treatment plans completed (and thus contributed that data), but sought treatment elsewhere. One patient was withdrawn after treatment. There are therefore only 15 of 20 enrolled patients actually assessable for adverse events.
Skin and subcutaneous tissue disorders Skin toxicity - grade 2	6.7% 1/15 • Number of events 1 • Cumulative adverse events were collected via regular 6 month patient follow-ups after the completion of treatment. There were 20 patients initially enrolled. One decided to not receive treatment after initial enrollment. Three had treatment plans completed (and thus contributed that data), but sought treatment elsewhere. One patient was withdrawn after treatment. There are therefore only 15 of 20 enrolled patients actually assessable for adverse events.
Endocrine disorders thyroid problem - grade 2	6.7% 1/15 • Number of events 1 • Cumulative adverse events were collected via regular 6 month patient follow-ups after the completion of treatment. There were 20 patients initially enrolled. One decided to not receive treatment after initial enrollment. Three had treatment plans completed (and thus contributed that data), but sought treatment elsewhere. One patient was withdrawn after treatment. There are therefore only 15 of 20 enrolled patients actually assessable for adverse events.

Additional Information

Bradford Hoppe, MD, MPH

University of Florida Proton Therapy Institute

Phone: 904-588-1800

Email: bhoppe@floridaproton.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place