Clinical trial NCT00365105
Conditions: Breast Cancer Lung Cancer Metastatic Cancer Pain Prostate Cancer
Keywords: pain bone metastases extensive stage small cell lung cancer recurrent breast cancer stage IV breast cancer recurrent non-small cell lung cancer stage IV non-small cell lung cancer recurrent prostate cancer stage IV prostate cancer
Sponsor: Radiation Therapy Oncology Group
Start date: 2006-07-11; Completion date: 2017-02-27
Enrollment: 261 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Zoledronate, vitamin D and calcium may prevent or delay bone pain and other symptoms caused by bone metastases. It is not yet known whether giving zoledronate together with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in treating patients with bone metastases from prostate cancer, lung cancer, or breast cancer.

PURPOSE: This randomized phase III trial is studying zoledronate, vitamin D, and calcium to see how well they work compared to zoledronate, vitamin D, calcium, and either strontium 89 or samarium 153 in preventing or delaying bone problems in patients with bone metastases from prostate cancer, lung cancer, or breast cancer.

Detailed description:
OBJECTIVES:

Primary

* Compare the efficacy of zoledronate, vitamin D, and calcium with or without strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium, in terms of preventing or delaying the time to development of malignant skeletal-related events (SREs) (defined as a pathological bone fracture, spinal cord compression, surgery to bone, or radiation to bone) in patients with bone metastases secondary to prostate, lung, or breast cancer.

Secondary

* Compare the rate of SREs at 1 year in patients treated with these regimens.
* Compare overall survival of patients treated with these regimens.
* Compare quality of life of patients treated with these regimens.
* Compare the effect of these regimens on pain control in these patients.
* Evaluate resource utilization and cost effectiveness of these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to primary disease site (prostate vs breast vs lung) and number of bone metastases (≤ 2 vs \> 2). Patients are randomized to 1 of 2 treatment arms.

Quality of life and pain are assessed at baseline and then at 1, 3, 6, and 12 months from start of protocol treatment.

After completion of study treatment, patients are followed every 6 months.

Arms: arm 1: Zoledronic acid, vitamin D and calcium supplements. arm 2: Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
Interventions: intervention 1: Calcium intervention 2: Vitamin D intervention 3: zoledronic acid intervention 4: Sm-153 intervention 5: Sr-89
Intervention descriptions: intervention 1: At least 500 mg of calcium (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop. intervention 2: 400 IU of vitamin D (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop. intervention 3: 4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop. intervention 4: Single dose intravenously 1 mCi/kg body weight. intervention 5: Single dose intravenously 4 mCi.

Protocol documents: