NCT00080912

Single vs Multiple-Fraction Therapy in Treating Patients With Previously Irradiated Painful Bone Metastases

A Phase III International Randomized Trial Of Single Versus Multiple Fractions For Re-Irradiation Of Painful Bone Metastases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 850 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether single-fraction (single-dose) re-irradiation therapy is as effective as multiple-fraction (many small doses of radiation therapy) re-irradiation therapy in relieving bone pain caused by bone metastases. PURPOSE: This randomized phase III trial is studying single-dose radiation therapy to see if it works as well as multiple-dose radiation therapy in treating patients previously irradiated with painful bone metastases.

Detailed description

OBJECTIVES: Primary * Compare pain relief in patients undergoing single-fraction vs multiple-fraction re-irradiation of painful bone metastases at 2 months after treatment. Secondary * Compare overall pain relief in patients treated with these regimens. * Compare time to pain progression in patients treated with these regimens. * Assess relationship between response to initial radiation and pain relief after re-irradiation in these patients. * Compare changes in functional interference after re-irradiation using the Brief Pain Inventory in patients treated with these regimens. * Compare quality of life of patients treated with these regimens (patients in Canada, France, the Netherlands, and patients registered through RTOG). * Determine characteristics of non-responders (to both initial and re-irradiation) among patients treated with these regimens. * Monitor the incidence of acute severe radiation-related side effects in patients treated with these regimens. * Monitor the incidence of in-field pathological fractures and spinal cord compression in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to response to initial radiotherapy (yes vs no), initial fractionation (single fraction vs multiple fraction), and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive single-fraction radiotherapy (8Gy) on day 1. * Arm II: Patients receive multiple-fraction radiotherapy (to a total of 20Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions. At least 4 weeks after the first re-treatment, patients in both arms may receive a second re-treatment at the discretion of the treating oncologist. Patients complete a Brief Pain Inventory questionnaire at baseline, on days 7 and 14, monthly during months 1-6, and at months 9 and 12. Acute Toxicities are assessed on days 7 and 14. Quality of Life is assessed at baseline and then monthly during months 1-6 for patients from participating groups. Patients are followed for up to 1 year. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 850 patients will be accrued for this study.

Conditions

• Metastatic Cancer
• Pain

Interventions

Type	Name	Description
RADIATION	radiation therapy	Given in a single fraction or multiple fractions

Timeline

• Start date: 2004-01-22
• Primary completion: 2013-04-10
• Completion: 2014-01-16
• First posted: 2004-04-08
• Last updated: 2023-08-21
• Results posted: 2015-02-26

Locations

12 sites across 1 country: Canada