Trial Outcomes & Findings for Cryoablation or External-Beam Radiation Therapy in Treating Patients With Painful Bone Metastases (NCT NCT00540969)
NCT ID: NCT00540969
Last Updated: 2018-11-21
Results Overview
TERMINATED
PHASE3
3 participants
at week 6
2018-11-21
Participant Flow
Participant milestones
| Measure |
Arm I (Percutaneous Cryoablation)
Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.
cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound
|
Arm II (External-beam Radiotherapy)
Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.
radiation therapy: Patients undergo radiotherapy for 1 week
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cryoablation or External-Beam Radiation Therapy in Treating Patients With Painful Bone Metastases
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: at week 6Population: Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at week 6Population: Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at week 6Population: Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Percutaneous Cryoablation)
Arm II (External-beam Radiotherapy)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place