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Clinical Trials (PDQ®)

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

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Alternate Title

Adjuvant Radiation Therapy in Treating Children With Hodgkin's Disease Who Respond to Combination Chemotherapy

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedunder 21 at diagnosisNCICCG-5942

Objectives

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.

Entry Criteria

Disease Characteristics:


Pathologically confirmed Hodgkin's disease of any stage
  Clinical staging must be available


Prior/Concurrent Therapy:


No prior therapy


Patient Characteristics:


Age:
  Under 21 at diagnosis

Other:
  Pre-existing cardiac or pulmonary dysfunction allowed at the study
  chairperson's discretion


Expected Enrollment

This study will accrue approximately 950 patients within 5 years.

Outline

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.

Published Results

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

James Nachman, MD, Protocol chair
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.

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