Phase II Trial of Conventional Versus IMRT Whole Brain Radiotherapy for Brain Metastases

In this study the patient will receive either whole brain radiation therapy given by intensity modulated radiation therapy (IMRT) or standard conventional radiation. In IMRT therapy radiation dose to the parts of the brain that do not contain tumors is reduced. This study will look to see if this approach results in less hair loss or fewer memory Problems, as compared to the standard technique. The study will also look at the effectiveness of both techniques in controlling the growth of the tumor.

Sex

All

Minimum age

18 Years

ELIGIBILITY CHECKLIST

Inclusion Criteria:

* Evidence of at least one brain metastasis on a gadolinium contrast-enhanced MRI
* Pathologic/histological/cytologic proof of a diagnosis of a non-hematopoietic malignancy within 5 years of study entry.
* Patient ≥18 years of age?
* Fall into RTOG Recursive Partition Analysis (RPA) class I or II.
* Karnofsky Performance Score ≥70. (See Appendix III)
* Biopsy done at least 1 week prior to registration. (This requirement does not apply to stereotactic biopsies.)

Exclusion Criteria:

* Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia.
* Creatinine level \> 1.4 mg/dl drawn ≤30 days prior to study entry.
* Severe, active co-morbitities.
* Unstable angina, and/or congestive heart failure requiring hospitalization within the last 6 months.
* Transmural myocardial infarction within the last 6 months
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* Uncontrolled, clinically significant cardiac arrhythmias
* Pregnancy

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• BACKGROUNDAoyama H, Shirato H, Tago M, Nakagawa K, Toyoda T, Hatano K, Kenjyo M, Oya N, Hirota S, Shioura H, Kunieda E, Inomata T, Hayakawa K, Katoh N, Kobashi G. Stereotactic radiosurgery plus whole-brain radiation therapy vs stereotactic radiosurgery alone for treatment of brain metastases: a randomized controlled trial. JAMA. 2006 Jun 7;295(21):2483-91. doi: 10.1001/jama.295.21.2483. PMID 16757720
• BACKGROUNDKocher M, Soffietti R, Abacioglu U, Villa S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Collette S, Collette L, Mueller RP. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. J Clin Oncol. 2011 Jan 10;29(2):134-41. doi: 10.1200/JCO.2010.30.1655. Epub 2010 Nov 1. PMID 21041710
• BACKGROUNDPatchell RA, Tibbs PA, Regine WF, Dempsey RJ, Mohiuddin M, Kryscio RJ, Markesbery WR, Foon KA, Young B. Postoperative radiotherapy in the treatment of single metastases to the brain: a randomized trial. JAMA. 1998 Nov 4;280(17):1485-9. doi: 10.1001/jama.280.17.1485. PMID 9809728
• BACKGROUNDGraham PH, Bucci J, Browne L. Randomized comparison of whole brain radiotherapy, 20 Gy in four daily fractions versus 40 Gy in 20 twice-daily fractions, for brain metastases. Int J Radiat Oncol Biol Phys. 2010 Jul 1;77(3):648-54. doi: 10.1016/j.ijrobp.2009.05.032. Epub 2009 Oct 14. PMID 19836153
• BACKGROUNDWong J, Hird A, Kirou-Mauro A, Napolskikh J, Chow E. Quality of life in brain metastases radiation trials: a literature review. Curr Oncol. 2008 Oct;15(5):25-45. doi: 10.3747/co.v15i5.290.