Aoki M, Sato M, Hirose K, Akimoto H, Kawaguchi H, Hatayama Y, Ono S, Takai Y Radiation-induced rib fracture after stereotactic body radiotherapy with a total dose of 54-56 Gy given in 9-7 fractions for patients with peripheral lung tumor: impact of maximum dose and fraction size. Radiat Oncol. 2015 Apr 22;10:99. doi: 10.1186/s13014-015-0406-8.
Common Terminology Criteria for Adverse Events (CTCAE) Version 4 3. US Department of Health, National Institutes of Health and National Cancer Institude. 2010. Published online: https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf
Gennari A, Conte P, Rosso R, Orlandini C, Bruzzi P Survival of metastatic breast carcinoma patients over a 20-year period: a retrospective analysis based on individual patient data from six consecutive studies. Cancer. 2005 Oct 15;104(8):1742-50.
Kim SS, Song SY, Kwak J, Ahn SD, Kim JH, Lee JS, Kim WS, Kim SW, Choi EK Clinical prognostic factors and grading system for rib fracture following stereotactic body radiation therapy (SBRT) in patients with peripheral lung tumors. Lung Cancer. 2013 Feb;79(2):161-6. doi: 10.1016/j.lungcan.2012.10.011. Epub 2012 Nov 20.
Kucharczyk MJ, Swaminath A Ablative Therapy for Metastatic Breast Cancer - A Systematic Review. Radiotherapy & Oncology. 2015;116(S1):S27-28.
LEKSELL L The stereotaxic method and radiosurgery of the brain. Acta Chir Scand. 1951 Dec 13;102(4):316-9.
Lutz S, Balboni T, Jones J et al Palliative radiation therapy for bone metastases: Update of an ASTRO Evidence-Based Guideline. Practical Radiation Oncology. Published online August 5 2016. www.practicalradonc.org/article/S1879-8500(16)30122-9/abstract
Mauri D, Pavlidis N, Polyzos NP, Ioannidis JP Survival with aromatase inhibitors and inactivators versus standard hormonal therapy in advanced breast cancer: meta-analysis. J Natl Cancer Inst. 2006 Sep 20;98(18):1285-91.
Milano MT, Katz AW, Zhang H, Okunieff P Oligometastases treated with stereotactic body radiotherapy: long-term follow-up of prospective study. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):878-86. doi: 10.1016/j.ijrobp.2011.08.036. Epub 2011 Dec 13.
Milano MT, Zhang H, Metcalfe SK, Muhs AG, Okunieff P Oligometastatic breast cancer treated with curative-intent stereotactic body radiation therapy. Breast Cancer Res Treat. 2009 Jun;115(3):601-8. doi: 10.1007/s10549-008-0157-4. Epub 2008 Aug 22.
Niibe Y, Hayakawa K Oligometastases and oligo-recurrence: the new era of cancer therapy. Jpn J Clin Oncol. 2010 Feb;40(2):107-11. doi: 10.1093/jjco/hyp167. Epub 2010 Jan 4. Review.
Tawfik H, Rostom Y, Elghazaly H All-oral combination of vinorelbine and capecitabine as first-line treatment in HER2/Neu-negative metastatic breast cancer. Cancer Chemother Pharmacol. 2013 Apr;71(4):913-9. doi: 10.1007/s00280-013-2082-4. Epub 2013 Jan 24.
Treasure T, Fiorentino F, Scarci M, Møller H, Utley M Pulmonary metastasectomy for sarcoma: a systematic review of reported outcomes in the context of Thames Cancer Registry data. BMJ Open. 2012 Oct 8;2(5). pii: e001736. doi: 10.1136/bmjopen-2012-001736. Print 2012.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.