Status:
COMPLETED
Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Childhood Favorable Prognosis Hodgkin Lymphoma
Childhood Lymphocyte Depletion Hodgkin Lymphoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE3
Brief Summary
This phase III trial is studying how well combination chemotherapy works when given before radiation therapy and/or additional chemotherapy in treating young patients with newly diagnosed Hodgkin's ly...
Detailed Description
OBJECTIVES: I. Investigate the paradigm of response-based therapy for low-risk Hodgkin's lymphoma by eliminating involved-field radiotherapy (IFRT) in patients who achieve a complete remission (CR) a...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed Hodgkin's lymphoma meeting the following criteria:
- Newly diagnosed disease
- Stage IA OR stage IIA without bulky disease
- No lymphocyte-predominant histology
- Staging on this study will be determined by the clinical stage; surgical staging is strongly discouraged, except for the rare situation of equivocal imaging studies below the diaphragm
- Patients may not have received any previous chemotherapy or radiation therapy; patients may not have received systemic corticosteroids within 30 days of enrollment on this protocol; steroids used for treatment of contrast agent allergy required for computed tomography (CT) scans are acceptable
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^3
- Total bilirubin =\< 1.5 x normal
- Alanine (ALT) =\< 2.5 x normal
- Shortening fraction \>= 27% by echocardiogram OR ejection fraction \>= 50% by multi-gated acquisition (MUGA)
- No pathologic prolongation of QTc interval on 12-lead electrocardiography (ECG)
- Female patients of childbearing potential must have a negative pregnancy test
- Lactating females must agree that they will not breastfeed a child while on this study
- Fertile patients must use effective contraception
- Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT00302003
Start Date
February 1 2006
End Date
June 30 2019
Last Update
March 30 2021
Active Locations (1)
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1
Children's Oncology Group
Arcadia, California, United States, 91006-3776