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Cryoablation or External-Beam Radiation Therapy in Treating Patients With Painful Bone Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00540969
Recruitment Status : Terminated (Low accrual)
First Posted : October 8, 2007
Results First Posted : February 1, 2017
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Kidney Cancer
Melanoma (Skin)
Metastatic Cancer
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Interventions Procedure: cryosurgery
Radiation: radiation therapy
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Percutaneous Cryoablation) Arm II (External-beam Radiotherapy)
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 2 1
Completed 2 1
Not Completed 0 0
Arm/Group Title Arm I (Percutaneous Cryoablation) Arm II (External-beam Radiotherapy) Total
Hide Arm/Group Description

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

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

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
1.Primary Outcome
Title Comparison of Pre- and Post-treatment Worst Pain in 24 Hours at Week 6 as Measured on the Numeric 0 to 10 Brief Pain Inventory (BPI) Scale
Hide Description [Not Specified]
Time Frame at week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
Arm/Group Title Arm I (Percutaneous Cryoablation) Arm II (External-beam Radiotherapy)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Average Difference in Pre- and Post-treatment Average Pain, Pain Relief, and Pain Interference Scores at Week 6 as Measured With the BPI
Hide Description [Not Specified]
Time Frame at week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
Arm/Group Title Arm I (Percutaneous Cryoablation) Arm II (External-beam Radiotherapy)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Average Difference in Pre- and Post-treatment Physical (PCS-8) and Mental (MCS-8) Quality of Life at Week 6 as Measured by the 2 Subscales of the Short Form (SF)-8
Hide Description [Not Specified]
Time Frame at week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
Arm/Group Title Arm I (Percutaneous Cryoablation) Arm II (External-beam Radiotherapy)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
 
Arm/Group Title Arm I (Percutaneous Cryoablation) Arm II (External-beam Radiotherapy)
Hide Arm/Group Description

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

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

All-Cause Mortality
Arm I (Percutaneous Cryoablation) Arm II (External-beam Radiotherapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Arm I (Percutaneous Cryoablation) Arm II (External-beam Radiotherapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Percutaneous Cryoablation) Arm II (External-beam Radiotherapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Matthew Callstrom, M.D., Ph.D.
Organization: Mayo Clinic
Phone: 5072664532
EMail: callstrom.matthew@mayo.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00540969    
Other Study ID Numbers: NCCTG-N06C6
NCI-2009-00690 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000570788 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: October 5, 2007
First Posted: October 8, 2007
Results First Submitted: December 7, 2016
Results First Posted: February 1, 2017
Last Update Posted: November 21, 2018