Trial Outcomes & Findings for Proton Beam Re-Irradiation in Thoracic Cancers (NCT NCT02204761)

NCT ID: NCT02204761

Last Updated: 2018-11-20

Results Overview

Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 generally means hospitalization required for management of side effects.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: Up to 3 months post-treatment
• Results posted on: 2018-11-20

Participant Flow

Participant milestones

Measure	Treatment (Proton Beam Radiation Therapy) Patients undergo proton beam radiation therapy per standard of care. Proton Beam Radiation Therapy: Undergo proton beam radiation therapy
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proton Beam Re-Irradiation in Thoracic Cancers

Baseline characteristics by cohort

Measure	Treatment (Proton Beam Radiation Therapy) n=6 Participants Patients undergo proton beam radiation therapy per standard of care. Proton Beam Radiation Therapy: Undergo proton beam radiation therapy
Age, Continuous	71.7 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 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	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants
Number of participants with Grade 3+ toxicity from radiation	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 months post-treatment

Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 generally means hospitalization required for management of side effects.

Outcome measures

Measure	Treatment (Proton Beam Radiation Therapy) n=6 Participants Patients undergo proton beam radiation therapy per standard of care. Proton Beam Radiation Therapy: Undergo proton beam radiation therapy
Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment	2 Participants

SECONDARY outcome

Timeframe: Up to 3 months post-treatment

Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. Grade 2 generally means medical therapy required to intervene due to toxicity.

Outcome measures

Measure	Treatment (Proton Beam Radiation Therapy) n=6 Participants Patients undergo proton beam radiation therapy per standard of care. Proton Beam Radiation Therapy: Undergo proton beam radiation therapy
Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment	2 Participants

SECONDARY outcome

Timeframe: Up to 3 months post-treatment

Number of participants who did not have local failure as defined by: tumor progression per Response Evaluation Criteria in Solid Tumors criteria - at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions inside the full dose radiation field.

Outcome measures

Measure	Treatment (Proton Beam Radiation Therapy) n=6 Participants Patients undergo proton beam radiation therapy per standard of care. Proton Beam Radiation Therapy: Undergo proton beam radiation therapy
Number of Participants With Local Control of Cancer	6 Participants

SECONDARY outcome

Timeframe: Up to 3 months post-treatment

Number of participants alive.

Outcome measures

Measure	Treatment (Proton Beam Radiation Therapy) n=6 Participants Patients undergo proton beam radiation therapy per standard of care. Proton Beam Radiation Therapy: Undergo proton beam radiation therapy
Number of Participants Alive	6 Participants

Adverse Events

Treatment (Proton Beam Radiation Therapy)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Proton Beam Radiation Therapy) n=6 participants at risk Patients undergo proton beam radiation therapy per standard of care. Proton Beam Radiation Therapy: Undergo proton beam radiation therapy
Skin and subcutaneous tissue disorders Dermatitis	16.7% 1/6 • Number of events 1 • 3 months
Nervous system disorders Pain	16.7% 1/6 • Number of events 1 • 3 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jing Zeng

University of Washington Medical Center

Phone: 2065984110

Email: jzeng13@uw.edu

Results disclosure agreements

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