Trial Outcomes & Findings for Proton Beam Radiation Therapy for Intraocular and Periocular Retinoblastoma (NCT NCT00432445)

Results Overview

Where proton beam radiation therapy used as an alternative to external photon beam irradiation in children with retinoblastoma as a means of local tumor control and ocular retention, local tumor control measured for participants with a globe as tumor regression with ocular retention, and for post enucleation measured as lack of orbital tumor recurrence.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

12 months

Results posted on

2015-02-27

Participant Flow

Recruitment Period: All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Study closed early due to low accrual, few eligible participants.

Participant milestones

Participant milestones
Measure	Proton Beam Radiation Therapy Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proton Beam Radiation Therapy for Intraocular and Periocular Retinoblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Proton Beam Radiation Therapy n=2 Participants Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: No analysis performed. Study did not meet anticipated enrollment.

Where proton beam radiation therapy used as an alternative to external photon beam irradiation in children with retinoblastoma as a means of local tumor control and ocular retention, local tumor control measured for participants with a globe as tumor regression with ocular retention, and for post enucleation measured as lack of orbital tumor recurrence.

Outcome measures

Outcome data not reported

Adverse Events

Proton Beam Radiation Therapy

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Proton Beam Radiation Therapy n=2 participants at risk Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
Eye disorders Retinopathy	50.0% 1/2 • Number of events 1 • Data collected at time point post radiation therapy for retinoblastoma at the following intervals: 3 months (+/- 1 month), 6 months (+/- 1 month), then annually (+/- 1 month) for the first five years. Overall study period: January 2007 to February 2014.

Other adverse events

Other adverse events
Measure	Proton Beam Radiation Therapy n=2 participants at risk Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
Eye disorders Post-radiation keratopathy	100.0% 2/2 • Number of events 2 • Data collected at time point post radiation therapy for retinoblastoma at the following intervals: 3 months (+/- 1 month), 6 months (+/- 1 month), then annually (+/- 1 month) for the first five years. Overall study period: January 2007 to February 2014.
Eye disorders Retinopathy	100.0% 2/2 • Number of events 2 • Data collected at time point post radiation therapy for retinoblastoma at the following intervals: 3 months (+/- 1 month), 6 months (+/- 1 month), then annually (+/- 1 month) for the first five years. Overall study period: January 2007 to February 2014.

Additional Information

Dan Gombos, MD/Professor, Ophthalmology

University of Texas (UT) MD Anderson Cancer Center

Phone: 713-792-6920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place