|Phase III||Treatment||Closed||16 and over||NCI||EST-1484|
I. Determine the complete response rate and toxicity of chemotherapy with CHOP (cyclophosphamide/adriamycin/vincristine/prednisone) for early stage non-Hodgkin's lymphoma of unfavorable (diffuse) histologic subtypes. II. Compare the effect of radiotherapy (administered to sites of pretreatment clinical involvement) following documented chemotherapy-induced complete response vs. chemotherapy alone with respect to duration of complete response, sites of relapse, survival, and toxicity. III. Assess the ability of radiotherapy to convert partial responders after chemotherapy (who have persistent localized disease) to restaged complete responders. IV. Determine the duration of complete response, sites of relapse, survival, and toxicity in patients who achieve complete response after radiotherapy.
Histologically confirmed Stage I/IE/II/IIE non-Hodgkin's lymphoma that is residual following incomplete resection One of the following histologic subtypes required: Diffuse large cell (histiocytic or immunoblastic) Diffuse mixed small and large cell (mixed histiocytic lymphocytic) Diffuse small cleaved cell (lymphocytic, poorly differentiated) Clinical or pathologic Stage I or IE tumors must have at least one of the following: Mediastinal or retroperitoneal involvement Bulky disease (tumor mass 10 cm or greater) Extranodal IE disease of any size Involvement of the following extranodal sites allowed: Waldeyer's ring (nasopharynx, tonsil, or base of tongue) Thyroid Lung or pleura (contiguous direct extension from adjacent nodes must be demonstrated) Breast Gastrointestinal tract (stomach, small bowel, or colon) Gynecologic organs (ovary, uterus, cervix) Bone (solitary direct extension from a nodal mass) Skin (direct extension from a nodal mass) Extranodal disease (i.e., lung mass, bone involvement, skin lesion) with noncontiguous extension from a lymph node region excluded Percutaneous bone marrow biopsy must be negative; abdominal CT scan required Disease may be measurable or nonmeasurable
Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Total prior resection not allowed Recovery from prior surgery required (generally at least 2 weeks postoperative) No postoperative evidence of active infection or complications
Age: 16 and over Performance status: Not specified Hematopoietic: WBC at least 4,000 Platelets at least 100,000 Hepatic: Bilirubin no greater than 2.0 mg/dl Renal: Creatinine no greater than 2.0 mg/dl BUN no greater than 30 mg/dl Cardiovascular: No CHF No severe coronary insufficiency No MI within 3 months Other: No active uncontrolled infection (bacterial, viral, fungal) No poorly controlled diabetes mellitus that would preclude high-dose prednisone No active uncontrolled nonmalignant duodenal ulcer
It is estimated that a total of 250 patients, of whom 175 will be complete responders, will be entered over 5 years. An accrual rate of 50 patients/year is anticipated. Because the CR rate was lower than expected and the rate of patient refusal of radiotherapy was higher than expected, the accrual target was increased to 325 patients. It is estimated that this increased accrual will require an additional 11 months of patient entry.
Randomized study. Partial responders on Arms I and II enter Regimen A. Arm I: 4-Drug Combination Chemotherapy. CHOP: Cyclophosphamide, CTX, NSC-26271; Adriamycin, ADR, NSC-123127; Vincristine, VCR, NSC-67574; Prednisone, PRED, NSC-10023. Arm II: 4-Drug Combination Chemotherapy followed by Radiotherapy (for complete responders). CHOP; followed by irradiation of sites of pretreatment involvement using megavoltage equipment. Regimen A: Radiotherapy. Irradiation of sites of pretreatment involvement and contiguous uninvolved regions using megavoltage equipment.Published Results
Horning SJ, Weller E, Kim K, et al.: Chemotherapy with or without radiotherapy in limited-stage diffuse aggressive non-Hodgkin's lymphoma: Eastern Cooperative Oncology Group study 1484. J Clin Oncol 22 (15): 3032-8, 2004.[PUBMED Abstract]
Glick JH, Kim K, Earle J, et al.: An ECOG randomized phase III trial of CHOP vs. CHOP + radiotherapy (XRT) for intermediate grade early stage non-Hodgkin's lymphoma (NHL). [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-1221, 391, 1995.
Trial Lead Organizations
Eastern Cooperative Oncology Group
|John Glick, MD, Protocol chair|
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.