Trials in Progress: Bone Metastases

The Trials in Progress series is intended to stimulate discussion about ongoing clinical trials and to promote collaboration across the oncology community. In each entry, summaries of ongoing research relating to a variety of cancers are presented.

Radiopharmaceuticals and Zoledronic Acid for Bone Metastases

Sponsor: Radiation Therapy Oncology Group

Identifier: NCT00365105

This phase III study is testing whether zoledronic acid, vitamin D, and calcium is superior to zoledronic acid, vitamin D, and calcium plus either strontium 89 or samarium 153 in the delaying of bone problems in patients with bone metastases from lung, breast, and prostate cancer. The primary outcome measure is the time to development of a malignant skeletal-related event (SRE). Secondary outcome measures include SRE at 1 year, overall survival, changes in quality of life, changes in pain control, and the utility and cost-effectiveness of the use of radiopharmaceuticals and bisphosphonates. The study is aiming to recruit about 352 patients, with an estimated primary completion date of March 2013.

Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases

Sponsor: University Hospital, Ghent

Identifier: NCT01429493

This phase II/III trial is designed to test the hypothesis that fluorodeoxyglucose positron emitting tomography (FDG-PET) can detect intra-bone metastasis regions within tumor-associated host-cell compartments responsible for pain. The primary outcome measure is the level of pain response (measured with the visual analogue scale) one month after radiotherapy. The secondary outcome measure is quality of life one month after radiotherapy. The estimated enrollment is 120 patients. The trial has an estimated completion date of January 2014.

F18PET/CT Versus TC-MDP Scanning to Detect Bone Mets

Sponsor: American College of Radiology - Image Metrix

ClinicalTrials.gov Identifier: NCT00882609

This phase III trial will analyze the diagnostic performance of 18F- Fluoride PET/CT scanning compared to conventional bone scanning in relation to bone metastasis. The trial will determine if 18F-Fluoride PET/CT will improve patient outcomes. The hypothesis is that PET/CT is superior to conventional bone scanning. The primary outcome measure is the analysis of diagnostic performance of 18F]NaF fluoride PET/CT scanning. This trial has an estimated enrollment of 550 patients with an estimated completion date of June 2013. This trial is currently enrolling.

Dexamethasone vs Placebo in the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases

Sponsor: NCIC Clinical Trials Group

ClinicalTrials.gov Identifier: NCT01248585

This phase III trial is currently recruiting patients. The trial is being conducted to determine the efficacy of dexamethasone to prevent pain flare caused by radiation to treat bone metastases. It remains unclear if dexamethasone can prevent pain flare or decrease the pain in these patients. The primary outcome measure is pain flare incidence, with a time frame of 10 days after the completion of treatment. Secondary outcome measures include, but are not limited to, pain score, analgesic use, response six weeks after radiation treatment, number of patients with adverse events, quality of life, QoL validation, inflammatory cytokines, bone turnover markers, and metabolism of drug. The estimated enrollment is 298 patients, with an estimated completion date of October 2015.

Study Comparing the Safety and Effectiveness of Magnetic Resonance Guided Focused Ultrasound (MRgFUS) and External Beam Radiation (EBRT) for Treatment of Metastatic Bone Tumors and Multiple Myeloma

The purpose of this phase III trial is to collect data on the safety and efficacy of MR Guided Focused Ultrasound and External Beam Radiation for treatment of metastatic bone tumors or multiple myeloma. The primary outcome measure of this trial is safety, with a time frame of six months. The secondary outcome measure is effectiveness, determined by the level of pain relief, descries in analgesics/opiate, and improved quality of life. This trial is recruiting and looks to enroll 60 patients.

Sponsor: InSightec

ClinicalTrials.gov Identifier: NCT01091883