Phase III Trial of CHOP (CTX/ADR/VCR/PRED) in Children with Localized non-Hodgkin's Lymphoma
Basic Trial Information
|Phase III||Treatment||Completed||21 and under||NCI||POG-8314|
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).
See General Eligibility Criteria
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.
126 patients will be entered over about 4.2 years.
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
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.