Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	under 18	NCI	CCG-541 CLB-7691, POG-7660

Objectives

I.  Compare the effectiveness of involved field radiotherapy followed by MOPP 
chemotherapy, and extended field radiotherapy, in treating 
laparotomy-confirmed Stage I and II Hodgkin's disease in children in terms of:
(A)  Duration of disease-free interval following completion of initial therapy.
(B)  The type and extent of disease following initial therapy.
(C)  Survival.
II.  Determine the retrievability of new disease following primary therapy for 
each of the three regimens, using specified retrieval plans.
III.  Determine the effect of specific histology on results of primary and 
retrieval therapy for each of the three regimens.
IV.  Determine the comparative effects of the three treatment regimens with 
respect to:
(A)  Linear growth, bi-acromial and bi-cristal diameters.
(B)  Incidence of hypothyroidism and sterility.
(C)  Incidence of second malignancies.
(D)  Complications following staging celiotomy and splenectomy, immediate and 
remote, including fulminating infections.
(E)  Effectiveness of penicillin prophylaxis in the prevention of 
post-splenectomy infectious complications.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients under 18 years of age with 
histologically confirmed Stage I and II untreated Hodgkin's disease.  Patients 
who have undergone either prior chemotherapy or radiotherapy are excluded 
except for patients with massive mediastinal disease who required local 
radiotherapy for tumor shrinkage.  Patients with Stage I unilateral upper neck 
disease of any histology other than lymphocytic depletion; patients with Stage 
I unilateral inguinal disease of any histology are excluded from randomization 
but are to be registered and followed on therapy as prescribed by their 
Principal Investigator.

Expected Enrollment

150 patients will be entered.  Protocol closed 06/81.

Outline

Randomized study.  Randomize POG patients to Arm I, II or IV only, all other 
patients to Arms II or III only.
Arm I:  Involved Field Radiotherapy.
Arm II:  Involved Field Radiotherapy, 3-Drug Combination Chemotherapy plus 
Hormone Therapy.  MOPP:  Nitrogen mustard, NM, NSC-762; Vincristine, VCR, 
NSC-67574; Procarbazine, PCB, NSC-77213; Prednisone, PRED, NSC-10023, for CCG 
and CLB patients.
Arm III:  Extended Field Radiotherapy.
Arm IV:  No further therapy.

Trial Contact Information

Trial Lead Organizations

Children's Cancer Group

G. Denman Hammond, MD, Protocol chair(Contact information may not be current)		Ph: 316-268-5000