Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain

Cancer Research UK (CRUK)

Status and phase: Completed; Phase 3

Conditions: Metastatic Cancer; Prostate Cancer; Pain

Treatments: Drug: ibandronate sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT00082927

CDR0000361728 (Registry Identifier)

ISRCTN86185157

EU-20224

CRUK-NCRI-RT-02-01

RIB

Details and patient eligibility

About

RATIONALE: Ibandronate may be effective in reducing bone pain caused by metastatic cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether ibandronate is more effective than standard treatment with radiation therapy in treating metastatic bone pain.

PURPOSE: This phase III randomized clinical trial is studying ibandronate to see how well it works compared to single-dose local radiation therapy in treating patients with localized metastatic bone pain.

Full description

OBJECTIVES:

Primary

• Compare pain response at 4 and 12 weeks post-treatment in patients with localized metastatic bone pain treated with single-dose ibandronate vs single-dose local radiotherapy .

Secondary

• Compare the quality of life of patients treated with these regimens.
• Correlate urinary markers of osteoclast activity (pyridinoline and deoxypyridinoline) with the clinical outcome of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, crossover, multicenter study. Patients are stratified according to primary tumor type and participating center. Patients are randomized into 1 of 2 treatment arms.

• Arm I: Patients receive a single dose of local radiotherapy to the site of pain (8Gy/1f).
• Arm II: Patients receive a single dose of ibandronate IV over 15 minutes. Patients who do not achieve a partial or complete response at 4 weeks crossover to the alternate arm.

Quality of life is assessed at baseline and then at 4 and 12 weeks. Pain is assessed at baseline, at 4, 8, and 12 weeks, and then at 6 months.

Patients are followed at 4, 8, and 12 weeks and then at 6 and 12 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 470 patients (235 per treatment arm) will be accrued for this study.

Enrollment: 580 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary prostate cancer OR sclerotic bone metastases (for patients with serum prostate-specific antigen > 100 ng/mL)

• Radiologically confirmed bone metastases by plain x-ray, isotope scan, CT scan, or MRI

• Clinical diagnosis of metastatic bone pain for which radiotherapy is indicated

• Single localized metastatic bone pain AND receiving optimal analgesics and adjuvant drugs, including non-steroidal anti-inflammatory drugs, unless contraindicated

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age

• Over 18

Sex

• Male

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• At least 3 months

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Creatinine ≤ 3.0 mg/dL
• No hypercalcemia (corrected calcium > 10.8 mg/dL)
• No hypocalcemia (corrected calcium < 8.2 mg/dL)

Other

• No known hypersensitivity to ibandronate or other bisphosphonates
• No history of aspirin-sensitive asthma
• Able to comply with pain chart and quality of life assessments

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• More than 4 weeks since prior change in systemic chemotherapy
• No prior high-dose chemotherapy (dose intensity > 3 times standard dose)

Endocrine therapy

• More than 4 weeks since prior change in hormonal therapy

Radiotherapy

• See Disease Characteristics
• No prior external beam radiotherapy to index site
• No prior systemic radioisotope therapy (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)

Surgery

• Not specified

Other

• More than 6 months since prior bisphosphonate treatment
• More than 4 weeks since prior aminoglycoside antibiotics
• More than 30 days since prior investigational drugs