Trial Outcomes & Findings for Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators (NCT NCT00706485)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

At time of procedure

Results posted on

2016-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Dural Brachytherapy Plaque Patients undergoing spine tumor resection will undergo dural plaque brachytherapy. Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dural Brachytherapy Plaque n=5 Participants Patients undergoing spine tumor resection will undergo dural plaque brachytherapy. Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	4 Participants n=99 Participants

PRIMARY outcome

Timeframe: At time of procedure

Outcome measures

Outcome measures
Measure	Dural Brachytherapy Plaque n=5 Participants Patients undergoing spine tumor resection will undergo dural plaque brachytherapy. Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes
Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use	5 participants

SECONDARY outcome

Timeframe: at 6 weeks and at three months after therapy, and every 6 months thereafter for four years, and then annually to year 10

Local failure is defined as: extension of the tumor margin\[s\] in any direction at least 5 mm beyond that present on the pre-treatment imaging studies or the appearance of -tumor in tissues previously scored as sites of sub-clinical disease. Local control is absence of local failure.

Outcome measures

Outcome measures
Measure	Dural Brachytherapy Plaque n=5 Participants Patients undergoing spine tumor resection will undergo dural plaque brachytherapy. Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes
Number of Participants With Local Control	5 participants

SECONDARY outcome

Timeframe: up to 10 years

Population: Study was closed without analysis of anatomic sites of failure. No data were collected for this outcome.

Marginal failure is defined as appearance of tumor growth at the margin of dural plaque.

Outcome measures

Outcome data not reported

Adverse Events

Dural Brachytherapy Plaque

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

Thomas F. DeLaney, M.D.

Massachusetts General Hospital

Phone: 617-726-6876

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place