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Clinical Trials (PDQ®)

Phase I/II Radiotherapy for Previously Untreated Patients with non-Hodgkin's Lymphoma Confined to the Brain Parenchyma

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase ITreatmentClosed18 and overNCIRTOG-8315
RTOG-83-15

Objectives

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.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

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.

Expected Enrollment

50 patients will be entered over about 3.5 years.

Outline

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.

Published Results

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]

Related Publications

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

Diana Furst Nelson, MD, Protocol chair (Contact information may not be current)
Ph: 507-284-2511

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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