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

Basic Trial Information

Objectives

I.  Determine whether involved field radiotherapy (discontinued per May 1987 
notice) improves remission induction, local control, disease-free survival, 
and survival in children with localized non-Hodgkin's lymphoma in favorable 
sites (Murphy Stages I and II).

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Previously untreated patients not 
over the age of 21 years at the time of diagnosis who have histologically 
proven diffuse non-Hodgkin's lymphoma.  Eligible histologies by the Rappaport 
classification include:  diffuse lymphoblastic (convoluted or nonconvoluted), 
diffuse histiocytic, and diffuse undifferentiated Burkitt's and non-Burkitt's 
type; those by the Lukes-Collins classification are lymphocytic (convoluted or 
undefined), immunoblastic sarcoma, histiocytic lymphoma, and follicular center 
cell (large cleaved and noncleaved, and small noncleaved).  Patients with 
greater than 5 percent blasts in a bone marrow aspirate and those with CNS 
involvement are not eligible; those with primary non-Hodgkin's lymphoma of 
skin localized to a single site or single site plus regional nodes are 
eligible.  Patients with localized non-Hodgkin's lymphoma of bone will be 
registered and treated on protocol with radiotherapy plus chemotherapy (no 
randomization) and analyzed separately.

Expected Enrollment

126 patients will be entered over about 4.2 years.

Outline

Randomized study.  All patients will receive Chemotherapy and all except those 
with a primary lymphoma of the bone will be randomized to receive or not to 
receive Radiotherapy.  All patients with bone lymphoma (including those with 
primary lymphomas of soft tissue with extension into bone or evidence of bony 
erosion) will receive Radiotherapy.  Per May 1987 notice, patients are no 
longer treated on the Radiotherapy plus Chemotherapy regimen, as sufficient 
patients have been accrued to that treatment combination.  Only patients with 
head and neck primaries will receive CNS Prophylaxis.
Induction:  4-Drug Combination Chemotherapy.  CHOP:  Cyclophosphamide, CTX, 
NSC-26271; Adriamycin, ADR, NSC-123127; Vincristine, VCR, NSC-67574; 
Prednisone, PRED, NSC-10023.
Consolidation:  4-Drug Combination Chemotherapy.  CHOP.
Maintenance:  2-Drug Combination Chemotherapy.  6-Mercaptopurine, 6-MP, 
NSC-755; Methotrexate, MTX, NSC-740.
CNS Prophylaxis:  Single-agent Intrathecal Chemotherapy.  MTX.
Radiotherapy (treatment discontinued per May 1987 notice):  Irradiation of 
areas of disease with Co60 or 4-6 MeV accelerators, with electron beam 
equipment for anterior boosts in the head and neck.

Link MP, Shuster JJ, Donaldson SS, et al.: Treatment of children and young adults with early-stage non-Hodgkin's lymphoma. N Engl J Med 337 (18): 1259-66, 1997.[PUBMED Abstract]

Link MP, Donaldson SS, Berard CW, et al.: Results of treatment of childhood localized non-Hodgkin's lymphoma with combination chemotherapy with or without radiotherapy. N Engl J Med 322 (17): 1169-74, 1990.[PUBMED Abstract]

Link MP, Donaldson SS, Berard CW, et al.: High cure rate with reduced therapy in localized non-Hodgkin's lymphoma (NHL) of childhood. [Abstract] Proceedings of the American Society of Clinical Oncology 6: A-749, 190, 1987.

Hutchison RE, Murphy SB, Fairclough DL, et al.: Diffuse small noncleaved cell lymphoma in children, Burkitt's versus non-Burkitt's types. Results from the Pediatric Oncology Group and St. Jude Children's Research Hospital. Cancer 64 (1): 23-8, 1989.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Pediatric Oncology Group

Michael Link, MD, Protocol chair		Ph: 650-723-5535 Email: mlink@stanford.edu

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