Phase I/II Radiotherapy for Previously Untreated Patients with non-Hodgkin's Lymphoma Confined to the Brain Parenchyma
Basic Trial Information
|Phase II, Phase I||Treatment||Closed||18 and over||NCI||RTOG-8315|
I. Estimate the median and 2-year disease-free survival rates for patients with primary non-Hodgkin's lymphoma confined to the brain parenchyma treated with 40 Gy to the whole brain and meninges, with a boost of 20 Gy to the tumor. II. Evaluate the immunologic status of these patients, and correlate this with the outcome of therapy.
See General Eligibility Criteria
See General Eligibility Criteria
General Eligibility Criteria:
Patients aged 18 years and older with histopathologically confirmed non-Hodgkin's lymphoma involving the parenchyma of the brain who have an estimated survival of at least 8 weeks and a Karnofsky performance status of at least 40 percent. There must be no evidence of systemic involvement by examination of superficial lymph nodes and Waldeyer's ring, chest x-ray, abdominal CT scan and/or lymphangiogram, and bone marrow biopsy. Patients must be not more than 4 weeks postoperative and must have recovered from the effects of surgery and any postoperative complications. There may have been no prior radiotherapy to the head or neck, no chemotherapy, and no radiosensitizer therapy. Bone marrow reserves must be adequate, and any anemia should be corrected by transfusion prior to entry. Patients may not have recurrent lymphoma, and there may be no history of a second malignancy other than small skin cancers not on the head or neck and carcinoma in situ of the cervix. Per January 1986 clarification, patients with acquired immune deficiency syndrome (AIDS) are not eligible for this study.
50 patients will be entered over about 3.5 years.
Nonrandomized study. Radiotherapy plus Anti-inflammatory Therapy. Whole brain irradiation with tumor boost, using megavoltage machines of energy ranging from Co60 to 10 MeV photons; plus Dexamethasone, DM, NSC-34521.
Nelson DF, Martz KL, Bonner H, et al.: Non-Hodgkin's lymphoma of the brain: can high dose, large volume radiation therapy improve survival? Report on a prospective trial by the Radiation Therapy Oncology Group (RTOG): RTOG 8315. Int J Radiat Oncol Biol Phys 23 (1): 9-17, 1992.[PUBMED Abstract]
Schultz C, Scott C, DeAngelis L, et al.: Radiation therapy (RT) alone vs. pre-RT chemotherapy (CTX) for the treatment of primary CNS lymphoma (PCNSL): age matched survival analysis of RTOG 83-15 and RTOG 93-10. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A617, 2000.
Corn B, Dolinskas C, Scott C, et al.: Strong correlation between imaging response and survival among patients with primary central nervous system lymphoma: a secondary analysis of RTOG studies 83-15 and 88-06. [Abstract] Proceedings of the Society for Neuro-Oncology A25, 1997.
Schultz C, Whittaker M, Kolesar P, et al.: EBV infection in immunocompetent patients with primary CNS lymphoma treated on RTOG 83-15 and 88-06. [Abstract] Proceedings of the Society for Neuro-Oncology A123, 1997.
Trial Contact Information
Trial Lead Organizations
Radiation Therapy Oncology Group
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