Trial Outcomes & Findings for Early-Phase Safety of Proton Therapy Equipment (NCT NCT02315989)

Last Updated: 2017-01-13

Results Overview

After enrollment, each patient has to receive physical examination, laboratory tests, and image studies as baseline. During the course of radiotherapy, patients will have weekly evaluations in physicals and laboratory tests. Image studies are optional during treatment. In the follow-up periods, monthly exams, including regular physicals, markers in serum and urine and image studies to evaluation treatment responses, will be scheduled till 90 days after the end of treatment.

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

Average 90 days after treatment.

Results posted on

2017-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	Safety proton therapy proton therapy: proton therapy
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early-Phase Safety of Proton Therapy Equipment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety n=6 Participants proton therapy proton therapy: proton therapy
Age, Continuous	61.5 years n=5 Participants
Gender Female	1 Participants n=5 Participants
Gender Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Average 90 days after treatment.

Outcome measures

Outcome measures
Measure	Safety n=6 Participants proton therapy proton therapy: proton therapy	Partial Response Partial Response(PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	Inevaluable Inevaluable (NE), Inevaluable for response: specify reasons (for example: early death, malignant disease; toxicity; tumor assessments not repeated/incomplete; other (specify).
Rate and Severity of Adverse Reactions	6 participants	—	—

SECONDARY outcome

Timeframe: Average 100 days after treatment.

During treatment, the frequency of operation of the system error will be recorded and analyzed to see if the system can run smoothly.

Outcome measures

Outcome measures
Measure	Safety n=6 Participants proton therapy proton therapy: proton therapy	Partial Response Partial Response(PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	Inevaluable Inevaluable (NE), Inevaluable for response: specify reasons (for example: early death, malignant disease; toxicity; tumor assessments not repeated/incomplete; other (specify).
Percentage of System Errors	12.7 percentage of system errors	—	—

SECONDARY outcome

Timeframe: Average 100 days after treatment.

Response Evaluation Criteria In Solid Tumors:(1)complete Response(CR),Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm (2)Partial Response(PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (3)Progressive Disease(PD), At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (4)Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (5) Inevaluable (NE), Inevaluable for response: specify reasons (for example: early death, malignant disease; toxicity; tumor assessments not repeated/incomplete; other (specify).

Outcome measures

Outcome measures
Measure	Safety n=6 Participants proton therapy proton therapy: proton therapy	Partial Response n=6 Participants Partial Response(PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	Inevaluable n=6 Participants Inevaluable (NE), Inevaluable for response: specify reasons (for example: early death, malignant disease; toxicity; tumor assessments not repeated/incomplete; other (specify).
Percentage of Each Target Lesion Evaluation Types.(1)Complete Response(2)Partial Response,(3)Progressive Disease,(4)Stable Disease,(5) Inevaluable	50 percentage of participants	16.67 percentage of participants	33.33 percentage of participants

Adverse Events

Safety

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Safety n=6 participants at risk proton therapy proton therapy: proton therapy
Blood and lymphatic system disorders White blood cell decreased	16.7% 1/6 • 6 months (August, 2014-February, 2015)
Skin and subcutaneous tissue disorders Dermatitis radiation	66.7% 4/6 • 6 months (August, 2014-February, 2015)
Gastrointestinal disorders Anal hemorrhage	16.7% 1/6 • 6 months (August, 2014-February, 2015)
Gastrointestinal disorders Rectal hemorrhage	16.7% 1/6 • 6 months (August, 2014-February, 2015)
Blood and lymphatic system disorders Anemia	16.7% 1/6 • 6 months (August, 2014-February, 2015)
Skin and subcutaneous tissue disorders Alopecia	16.7% 1/6 • 6 months (August, 2014-February, 2015)
Gastrointestinal disorders Mucositis oral	33.3% 2/6 • 6 months (August, 2014-February, 2015)
Nervous system disorders Dysgeusia	16.7% 1/6 • 6 months (August, 2014-February, 2015)
Gastrointestinal disorders Dysphagia	33.3% 2/6 • 6 months (August, 2014-February, 2015)
Gastrointestinal disorders Dry mouth	33.3% 2/6 • 6 months (August, 2014-February, 2015)
Gastrointestinal disorders Lip pain	33.3% 2/6 • 6 months (August, 2014-February, 2015)
Gastrointestinal disorders Edema face	16.7% 1/6 • 6 months (August, 2014-February, 2015)
Musculoskeletal and connective tissue disorders Trismus	16.7% 1/6 • 6 months (August, 2014-February, 2015)
Gastrointestinal disorders Constipation	16.7% 1/6 • 6 months (August, 2014-February, 2015)

Additional Information

Hong, Ji-Hong M.D.

Linkou Chang Gung Memorial Hospital

Phone: 03-3281200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place