Trial Outcomes & Findings for Conformal High Dose Intensity Modulated Radiation Therapy for Disease to Thoracic and Lumbar Spine (NCT NCT01654068)

NCT ID: NCT01654068

Last Updated: 2019-04-19

Results Overview

Time to any skeletal related event most commonly symptomatic recurrence or progression with pain/neurologic impairment with evidence of radiographic progression (median local progression-free survival).

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: up to 24 months
• Results posted on: 2019-04-19

Participant Flow

Participant milestones

Measure	Radiation Therapy to Local Spine Metastasis Conformal High Dose Intensity Modulated Radiation Therapy Conformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Conformal High Dose Intensity Modulated Radiation Therapy for Disease to Thoracic and Lumbar Spine

Baseline characteristics by cohort

Measure	Radiation Therapy to Local Spine Metastasis n=14 Participants Conformal High Dose Intensity Modulated Radiation Therapy Conformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants
Smoking Status Never Smoker	5 Participants n=5 Participants
Smoking Status Former Smoker	8 Participants n=5 Participants
Smoking Status Current Smoker	1 Participants n=5 Participants
Site of Metastasis Thoracic Spine	10 Participants n=5 Participants
Site of Metastasis Lumbar Spine	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 24 months

Time to any skeletal related event most commonly symptomatic recurrence or progression with pain/neurologic impairment with evidence of radiographic progression (median local progression-free survival).

Outcome measures

Measure	Radiation Therapy to Local Spine Metastasis n=14 Participants Conformal High Dose Intensity Modulated Radiation Therapy Conformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons
Time to Any Skeletal Related Event	75 weeks Interval 33.0 to 75.0

SECONDARY outcome

Timeframe: 90 days

The number of acute side effects of radiation therapy will be documented (≤ 90 days from start of radiation therapy)

Outcome measures

Measure	Radiation Therapy to Local Spine Metastasis n=14 Participants Conformal High Dose Intensity Modulated Radiation Therapy Conformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons
Acute Radiation Toxicity	1 event (possible acute side effect)

SECONDARY outcome

Timeframe: 2 years

The number of late side effects of radiation therapy will be documented (> 90 days after the start of radiation therapy)

Outcome measures

Measure	Radiation Therapy to Local Spine Metastasis n=14 Participants Conformal High Dose Intensity Modulated Radiation Therapy Conformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons
Late Radiation Toxicity	2 events (possible late side effects)

Adverse Events

Radiation Therapy to Local Spine Metastasis

Serious events: 2 serious events

Other events: 1 other events

Deaths: 11 deaths

Serious adverse events

Measure	Radiation Therapy to Local Spine Metastasis n=14 participants at risk Conformal High Dose Intensity Modulated Radiation Therapy Conformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons
Musculoskeletal and connective tissue disorders Vertebral Compression Fractures	14.3% 2/14 • Number of events 2 • 0-209 weeks

Other adverse events

Measure	Radiation Therapy to Local Spine Metastasis n=14 participants at risk Conformal High Dose Intensity Modulated Radiation Therapy Conformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons
Musculoskeletal and connective tissue disorders Bilateral Leg Pain	7.1% 1/14 • Number of events 1 • 0-209 weeks

Additional Information

Ronal McGarry

University of Kentucky

Phone: 859-323-6486

Email: rcmcga2@email.uky.edu

Results disclosure agreements

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