Phase 3
N=287
Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma
Childhood Favorable Prognosis Hodgkin Lymphoma · Childhood Lymphocyte Depletion Hodgkin Lymphoma · Childhood Mixed Cellularity Hodgkin Lymphoma · Childhood Nodular Sclerosis Hodgkin Lymphoma · Stage I Childhood Hodgkin Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00302003 ↗Enrolled (actual)
287
Serious AEs
0.7%
Results posted
Feb 2017
Primary outcome: Primary: Event Free Survival Without Receiving Radiation Therapy (EFSnoRT). — 0.49 Probability of survival
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- radiation therapy (Radiation); doxorubicin hydrochloride (Drug); vincristine sulfate (Drug); prednisone (Drug); cyclophosphamide (Drug); ifosfamide (Drug); vinorelbine tartrate (Drug); dexamethasone (Drug); etoposide phosphate (Drug); cisplatin (Drug); cytarabine (Drug); filgrastim (Biological)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event Free Survival Without Receiving Radiation Therapy (EFSnoRT). |
0.49 | — |
| PRIMARY Intensive Therapy Free Survival (ITFS). |
0.89 | — |
| PRIMARY Event Free Survival (EFS) |
0.79 | — |
| SECONDARY Overall Survival |
0.99 | — |
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 lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination chemotherapy) and giving them together with radiation therapy may kill more cancer cells.
Eligibility Criteria
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 = = 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
Data sourced from ClinicalTrials.gov (NCT00302003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.