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Safety and Efficacy of Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases

NCT01461252 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-07-16

No results posted yet for this study

Summary

This study will evaluate the safety and efficacy of cryoablation therapy combined with radiation therapy for the relief of pain associated with metastatic bone tumors.

Conditions

  • Pain
  • Neoplasm Metastasis

Interventions

PROCEDURE

Cryoablation

For cryoablation in the palliation of painful bone metastases, subject preparation, anesthesia, intra-operative monitoring, and postoperative management are identical to those of standard cryoablation routinely performed at all clinical centers participating in this study and are at the discretion of the investigator.

PROCEDURE

Radiation

Radiation therapy is usually performed with 6-18 Megavolt photons from a linear accelerator. The proposed dose and frequency of radiation for this protocol are: 8 Gray in 1 fraction, 30 Gray in 10 fractions, or 37.5 Gray in 15 fractions. These proposed doses or other doses will be prescribed at the discretion of the investigator. It is anticipated that subjects will begin the radiation therapy approximately within one to three weeks after the cryoablation procedure. The doses and frequency of the radiation treatment will be collected as well as toxicities.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Jerry Matteo, MD · Shands Medical Center, Jacksonville, FL

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-03-31
Completion
2014-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01461252 on ClinicalTrials.gov