Phase 3
N=1,734
Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease
Childhood Lymphocyte-Depleted Classical Hodgkin Lymphoma · Childhood Mixed Cellularity Classical Hodgkin Lymphoma · Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma · Childhood Nodular Sclerosis Classical Hodgkin Lymphoma · Stage I Childhood Hodgkin Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00025259 ↗Enrolled (actual)
1,734
Serious AEs
0.8%
Results posted
Mar 2017
Primary outcome: Primary: Event-free Survival — 0.89; 0.87; 0.84; 0.87 Probability of survival
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bleomycin Sulfate (Biological); Cisplatin (Drug); Cyclophosphamide (Drug); Cytarabine (Drug); Dexamethasone (Drug); Doxorubicin Hydrochloride (Drug); Etoposide (Drug); Filgrastim (Biological); Involved-Field Radiation Therapy (Radiation); Prednisone (Drug); Vincristine Sulfate Liposome (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-free Survival |
0.89; 0.87; 0.84; 0.87; 0.70; 0.79 | — |
| SECONDARY Disease Response Assessed by Modified RECIST Criteria |
5; 370; 380; 538; 29; 105 | — |
| SECONDARY Grade 3 or 4 Non-hematologic Toxicity |
10; 153; 130; 216; 11; 62 | — |
| SECONDARY Overall Survival |
0.93; 0.98; 0.98; 0.98; 0.96; 0.93 | — |
Summary
This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
Eligibility Criteria
Inclusion Criteria
- Patients with newly diagnosed, pathologically confirmed Hodgkin disease (all histologies) are eligible for this protocol if they meet the following clinical stage guidelines:
- All Stage IB regardless of bulk disease
- All Stage IIB regardless of bulk disease
- Stage IA only with bulk disease
- Stage IIA only with bulk disease
- All Stage IAE, IIAE regardless of bulk disease
- All Stage IIIA, IIIAE, IIIAS, IIIAE+S regardless of bulk disease
- All Stage IVA, IVAE regardless of bulk disease
- May not be staged by laparotomy alone
- Surgically staged patients must also have presurgical staging
- Bilirubin no greater than 1.5 times normal
- SGOT or SGPT less than 2.5 times normal
- Creatinine no greater than 1.5 times normal
- Creatinine clearance greater than 40 mL/min
- Radioisotope glomerular filtration rate greater than 70 mL/min
- Shortening fraction at least 27% by echocardiogram
- Ejection fraction at least 50% by MUGA
- No pathologic prolongation of QTc interval on 12-lead electrocardiogram
- FEV\_1/FVC greater than 60% by pulmonary function test
- Pulse oximetry greater than 94%
- No evidence of dyspnea at rest
- No exercise intolerance
- Adequate venous access
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior chemotherapy
- At least 1 month since prior corticosteroids except prednisone for respiratory distress
- No prior radiotherapy
Data sourced from ClinicalTrials.gov (NCT00025259). 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.