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Sponsors and Collaborators: |
NCIC Clinical Trials Group National Cancer Institute (NCI) Radiation Therapy Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00080912 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether single-fraction (single-dose) radiation therapy is more effective than multiple-fraction reirradiation (many small doses of radiation therapy) in relieving bone pain caused by bone metastases.
PURPOSE: This randomized phase III trial is studying single-dose radiation therapy to see how well it works compared to multiple-dose radiation therapy in treating patients with painful bone metastases.
Condition | Intervention | Phase |
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Metastatic Cancer Pain |
Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Phase III International Randomized Trial Of Single Versus Multiple Fractions For Re-Irradiation Of Painful Bone Metastases |
Estimated Enrollment: | 650 |
Study Start Date: | January 2004 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive single-fraction radiotherapy on day 1.
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Radiation: radiation therapy
Given in a single fraction or multiple fractions
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Arm II: Active Comparator
Patients receive multiple-fraction radiotherapy once daily on days 1-5 or on days 1-8 if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.
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Radiation: radiation therapy
Given in a single fraction or multiple fractions
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OBJECTIVES:
Primary
Secondary
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.
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.
Patients are followed for up to 1 year.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 650 patients (325 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignancy
Bone metastases at clinically painful areas confirmed by any of the following:
Initial radiotherapy field is reproducible for re-irradiation
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No prior radiotherapy dose ≥ 24 Gy in 6 fractions, 27 Gy in 8 fractions, or 30 Gy in 10 fractions to the spine or any part of the pelvis encompassing small or large bowel and/or the rectum, if these sites are being treated on study
Surgery
Other
Study Chair: | Edward L.W. Chow, MD | Edmond Odette Cancer Centre at Sunnybrook |
Study Chair: | William F. Hartsell, MD | Alexian Brothers Radiation Oncology |
Responsible Party: | NCIC-Clinical Trials Group ( Regulatory Affairs Associate ) |
Study ID Numbers: | CDR0000357423, CAN-NCIC-SC20, RTOG-0433, TROG 03.08 |
Study First Received: | April 7, 2004 |
Last Updated: | September 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00080912 History of Changes |
Health Authority: | Unspecified |
bone metastases pain |
Neoplasm Metastasis Pain |
Neoplasms Neoplastic Processes Pathologic Processes Neoplasm Metastasis |