Phase III Study of Adjuvant Low-Dose Involved-Field Radiotherapy vs No Adjuvant Therapy in Children with Hodgkin's Disease in CR Following Chemotherapy Assigned by Clinical Stage
Adjuvant Radiation Therapy in Treating Children With Hodgkin's Disease Who Respond to Combination Chemotherapy
Basic Trial Information
|Phase III||Treatment||Closed||under 21 at diagnosis||NCI||CCG-5942|
I. Determine the role of adjuvant low-dose, involved-field radiotherapy (IFRT) in pediatric patients with Hodgkin's disease who attain a complete response (CR) following initial chemotherapy. II. Determine the CR, event-free survival, and overall survival rates for pediatric patients with clinical Stage I-IV Hodgkin's disease treated with COPP/ABV hybrid chemotherapy (cyclophosphamide, vincristine, procarbazine, prednisone and doxorubicin, bleomycin, vinblastine): 4 courses for favorable prognosis disease and 6 courses for all others. III. Determine the CR, event-free survival, and overall survival rates for patients with clinical Stage IV Hodgkin's disease treated with a new intensive chemotherapy program involving cytarabine/etoposide (ARA-C/VP-16), COPP/ABV, and CHOP (cyclophosphamide, vincristine, doxorubicin, methylprednisolone, prednisone) with concurrent growth factor therapy. IV. Estimate the response rate of Stage IV Hodgkin's disease to 1 course of ARA-C/VP-16. V. Compare event-free survival in Stage IV disease patients receiving new intensive chemotherapy to an historical series of patients who received standard therapy. VI. Determine the incidence of therapy-related late effects, including second malignant neoplasms, sterility, cardiac dysfunction, pulmonary restrictive disease, growth abnormalities, and thyroid disease, in children with Hodgkin's disease treated with COPP/ABV chemotherapy with or without low-dose IFRT (Stage I-III patients) or ARA-C/VP-16, COPP/ABV, and CHOP with or without low-dose IFRT (Stage IV patients). VII. Evaluate prospectively prognostic factors that may predispose to treatment failure in pediatric patients with Hodgkin's disease. VIII. Examine the impact of the omission of low-dose IFRT on the long-term adverse effects of treatment in pediatric patients with Hodgkin's disease.
Pathologically confirmed Hodgkin's disease of any stage Clinical staging must be available
No prior therapy
Age: Under 21 at diagnosis Other: Pre-existing cardiac or pulmonary dysfunction allowed at the study chairperson's discretion
This study will accrue approximately 950 patients within 5 years.
Patients with favorable Stage IA/IB/IIA disease (no bulky disease, no hilar adenopathy, and fewer than 4 nodal sites) are treated on Regimen A; other Stage I/II and all Stage III patients are treated on Regimen B. Stage IV patients are treated on Regimen C. All patients who achieve a CR on Regimens A, B, or C are then randomized to Arms I and II; Stage I-IV patients who achieve a PR are nonrandomly assigned to Arm I. The following acronyms are used: ARA-C Cytarabine, NSC-63878 BLEO Bleomycin, NSC-125066 CTX Cyclophosphamide, NSC-26271 DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 MePRDL Methylprednisolone, NSC-19987 PCB Procarbazine, NSC-77213 PRED Prednisone, NSC-10023 VBL Vinblastine, NSC-49842 VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540 Regimen A: 7-Drug Combination Chemotherapy. COPP/ABV: CTX/VCR/PCB/PRED/DOX/BLEO/VBL. 4 courses of therapy. Regimen B: 7-Drug Combination Chemotherapy. COPP/ABV. 6 courses of therapy. Regimen C: 2-Drug Combination Chemotherapy followed by 7-Drug Combination Chemotherapy followed by 5-Drug Combination Chemotherapy. ARA-C/VP-16; followed by COPP/ABV; followed by CHOP: CTX/VCR/DOX/MePRDL/PRED. Arm I: Radiotherapy. Involved-field irradiation using 4-10 MV x-rays (preferred) or Co60 sources (electrons allowed for Stage I superficial inguinal or femoral disease) with, as appropriate, boost irradiation to sites of residual disease. Arm II: Control. No radiotherapy.
Appel BE, Chen L, Buxton A, et al.: Impact of low-dose involved-field radiation therapy on pediatric patients with lymphocyte-predominant Hodgkin lymphoma treated with chemotherapy: a report from the Children's Oncology Group. Pediatr Blood Cancer 59 (7): 1284-9, 2012.[PUBMED Abstract]
Wolden SL, Chen L, Kelly KM, et al.: Long-term results of CCG 5942: a randomized comparison of chemotherapy with and without radiotherapy for children with Hodgkin's lymphoma--a report from the Children's Oncology Group. J Clin Oncol 30 (26): 3174-80, 2012.[PUBMED Abstract]
Nachman J, Sposto R, Herzog P, et al.: Low dose involved field radiation (IFRT) or no further treatment following complete response to initial chemotherapy in young adult (YA) patients 16-21 years of age with Hodgkin's disease (HD): the Children's Cancer Group (CCG) experience. [Abstract] J Clin Oncol 23 (Suppl 16): A-8513, 803s, 2005.
Nachman JB, Sposto R, Herzog P, et al.: Randomized comparison of low-dose involved-field radiotherapy and no radiotherapy for children with Hodgkin's disease who achieve a complete response to chemotherapy. J Clin Oncol 20 (18): 3765-71, 2002.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Children's Cancer Group
Ph: 773-702-6808; 888-824-0200
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.