A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain


Phase 3
18 Years
N/A
Not Enrolling
Both
Metastatic Cancer, Pain, Prostate Cancer

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Trial Information

A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Principal Investigator

Heather Purnell

Investigator Affiliation:

Cancer Research UK

Authority:

United States: Federal Government

Study ID:

CRUK-NCRI-RT-02-01

NCT ID:

NCT00082927

Start Date:

April 2003

Completion Date:

July 2011

Related Keywords:

  • Metastatic Cancer
  • Pain
  • Prostate Cancer
  • stage IV prostate cancer
  • bone metastases
  • pain
  • recurrent prostate cancer
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Prostatic Neoplasms

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