Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00302003|
Recruitment Status : Active, not recruiting
First Posted : March 13, 2006
Results First Posted : February 9, 2017
Last Update Posted : February 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|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 Stage II Childhood Hodgkin Lymphoma||Radiation: radiation therapy Drug: doxorubicin hydrochloride Drug: vincristine sulfate Drug: prednisone Drug: cyclophosphamide Drug: ifosfamide Drug: vinorelbine tartrate Drug: dexamethasone Drug: etoposide phosphate Drug: cisplatin Drug: cytarabine Biological: filgrastim||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||287 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Study for the Treatment of Children and Adolescents With Newly Diagnosed Low Risk Hodgkin Disease|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||March 2012|
Experimental: Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.
Radiation: radiation therapy
Undergo radiation therapy
Other Names:Drug: doxorubicin hydrochloride
Other Names:Drug: vincristine sulfate
Other Names:Drug: prednisone
Other Names:Drug: cyclophosphamide
Other Names:Drug: ifosfamide
Other Names:Drug: vinorelbine tartrate
Other Names:Drug: dexamethasone
Other Names:Drug: etoposide phosphate
Other Names:Drug: cisplatin
Other Names:Drug: cytarabine
Other Names:Biological: filgrastim
Given IV or subcutaneously
- Event Free Survival Without Receiving Radiation Therapy (EFSnoRT). [ Time Frame: At 60 months ]Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT).
- Intensive Therapy Free Survival (ITFS). [ Time Frame: At 60 months ]Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy.
- Event Free Survival (EFS) [ Time Frame: At 60 months ]Survival is defined as the minimum time from study entry to a relapse of any kind, death from any cause, or occurrence of a second malignant neoplasm. Patients without report of such events where censored at last contact. This will be used to compute event free survival (EFS).
- Overall Survival [ Time Frame: At 60 months ]Survival is defined as time from study entry to death due to any cause. Patients alive at last contact where censored at last contact.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302003
|United States, California|
|Children's Oncology Group|
|Arcadia, California, United States, 91006-3776|
|Principal Investigator:||Frank Keller, MD||Children's Oncology Group|