Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT00540969
Brief Summary:
RATIONALE: Cryoablation kills cancer cells by freezing them. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether cryoablation is more effective than external-beam radiation therapy in treating painful bone metastases.
PURPOSE: This randomized phase III clinical trial is studying cryoablation to see how well it works compared with external-beam radiation therapy in treating patients with painful bone metastases.
Detailed Description:
OBJECTIVES:
* To determine pain relief in cancer patients with painful metastatic disease involving bone following treatment with cryoablation as compared to radiotherapy (RT).
* To compare the impact on quality-of-life following cryoablation or RT in patients with painful metastatic disease as measured using the validated Brief Pain Inventory (BPI) and Short Form (SF)-8.
* To determine change in analgesic use following therapy.
* To determine the frequency and severity of complications following treatment of painful metastases involving bone with either cryoablation or RT.
OUTLINE: This is a multicenter study. Patients are stratified according to size of the indexing lesion (≤ 5 cm vs \> 5 cm), location of the target lesion (pelvis vs extremity vs vertebral body vs other), primary cancer type (melanoma or renal cell carcinoma vs other), and severity of pain (i.e., worst pain score in the last 24-hour period) (4-6 vs 7-10). Patients are randomized to 1 of 2 treatment arms.
* 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.
* 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.
Patients are contacted via phone on days 1 and 4 post treatment, weekly in weeks 1-4, every 2 weeks in weeks 6-24, and then every four weeks in weeks 28-36. Patients undergo pain and pain interference with daily life assessment at baseline and at these time points. Patients who elect to have repeated treatment (either radiotherapy or cryoablation) within the first 6 weeks after the initial treatment are removed from the study. Patients who fail to achieve a 2-point reduction in worst or average pain (in a 24-hour period) during weeks 6-20 after initial treatment and patients who report a return of pain (i.e., pain ≥ the worst pain in a 24-hour period reported at baseline) for 2 consecutive time points are offered the alternative treatment (radiotherapy or cryoablation, whichever the patient was not randomized to receive at initial treatment)\*.
NOTE: \*Patients who refuse to receive the alternative treatment are taken off study.
Study:
NCT00540969
Study Brief:
Protocol Section:
NCT00540969