Clinical trial · Interventional
Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
Randomized Trial of Palliative Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life
NCT00003162CI-TRIAL-00019815completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective for bone metastases. PURPOSE: Randomized phase III trial to compare different radiation therapy regimens in treating patients who have bone metastases from breast or prostate cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Pain | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pain therapy | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 3.0 Gy x 10 fractions in two weeks
- description
- 3.0 Gy x 10 fractions for a total dose of 30.0 Gy in two weeks
- interventionNames
- Procedure: pain therapy
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- 8.0 Gy x 1 fraction
- description
- 8.0 Gy x 1 fraction for a total dose of 8.0 Gy in a single dose
- interventionNames
- Procedure: pain therapy
- Radiation: radiation therapy
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically proven breast or prostate cancer
* Radiographic evidence of bone metastasis within 8 weeks of study
* Eligible treatment sites:
* Weight-bearing sites:
* Pelvis (excluding pubis)
* Femur
* Sacrum and/or sacroiliac joints
* Tibia
* Non-weight-bearing sites:
* Up to 5 consecutive cervical, thoracic, or lumbar vertebral bodies
* Lumbosacral spine
* Up to 3 consecutive ribs
* Humerus
* Fibula
* Radius with/without ulna
* Clavicle
* Scapula
* Pubis
* If multiple sites are treated, site is included as weight bearing if any of the sites include the pelvis, sacrum, femur, or tibia
* Worst pain score of at least 5 on a scale of 10
* No skull, feet, or hand metastases
* No spinal cord or cauda equina compression/effacement in vertebral metastases
* Multiple sites eligible if they can be included in no greater than 3 treatment sites
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 40-100%
Life expectancy:
* At least 3 months
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No impending fracture of the treatment site
* No hematologic primary malignancies
* Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No change in immunotherapy within 30 days
Chemotherapy:
* No change in chemotherapy within 30 days
Endocrine therapy:
* No change in hormonal therapy within 30 days
Radiotherapy:
* No prior radiation therapy to treatment area
* At least 30 days since systemic radiotherapy (Sr 89)
Surgery:
* No prior palliative surgery to treatment area
* No planned surgical fixation of the boneReferences
Publications (11)
- BACKGROUNDKonski A, James J, Hartsell W, Leibenhaut MH, Janjan N, Curran W, Roach M, Watkins-Bruner D. Economic analysis of radiation therapy oncology group 97-14: multiple versus single fraction radiation treatment of patients with bone metastases. Am J Clin Oncol. 2009 Aug;32(4):423-8. doi: 10.1097/COC.0b013e31818da9f7. PMID 19546803
- BACKGROUNDBruner DW. Outcomes research in cancer symptom management trials: the Radiation Therapy Oncology Group (RTOG) conceptual model. J Natl Cancer Inst Monogr. 2007;(37):12-5. doi: 10.1093/jncimonographs/lgm004. PMID 17951225
- BACKGROUNDJuliano JJ, Reddy CA, Videtic GMM: How fast does practice change? A single-institution experience in utilization of a single fraction for palliation of bone metastases before and after RTOG 9714. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2561, S521-2, 2006.
- RESULTChow E, James J, Barsevick A, Hartsell W, Ratcliffe S, Scarantino C, Ivker R, Roach M, Suh J, Petersen I, Konski A, Demas W, Bruner D. Functional interference clusters in cancer patients with bone metastases: a secondary analysis of RTOG 9714. Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1507-11. doi: 10.1016/j.ijrobp.2009.04.024. Epub 2009 Jul 23. PMID 19632065
- RESULTHowell DD, James JL, Hartsell WF, et al.: Randomized trial of short-course versus long-course radiotherapy for palliation of painful vertebral bone metastases: A retrospective analysis of RTOG 97-14. [Abstract] J Clin Oncol 27 (Suppl 15): A-9521, 2009.
- RESULTHartsell WF, Desilvio M, Bruner DW, Scarantino C, Ivker R, Roach M 3rd, Suh J, Demas WF, Movsas B, Petersen IA, Konski AA. Can physicians accurately predict survival time in patients with metastatic cancer? Analysis of RTOG 97-14. J Palliat Med. 2008 Jun;11(5):723-8. doi: 10.1089/jpm.2007.0259. PMID 18588404
- RESULTKonski A, Desilvio M, Hartsell W, Watkins-Bruner D, Coyne J, Scarantino C, Janjan N. Continuing evidence for poorer treatment outcomes for single male patients: retreatment data from RTOG 97-14. Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):229-33. doi: 10.1016/j.ijrobp.2006.04.005. Epub 2006 Jul 11.