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Study 20 of 6183 for search of: | United States, Illinois |
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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00302003 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: cisplatin Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: etoposide phosphate Drug: filgrastim Drug: ifosfamide Drug: prednisone Drug: vincristine sulfate Drug: vinorelbine ditartrate Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase III Study for the Treatment of Children and Adolescents With Newly Diagnosed Low Risk Hodgkin's Disease |
Estimated Enrollment: | 400 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
After completion of study treatment, patients are followed periodically for up to 10 years.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed Hodgkin's lymphoma meeting the following criteria:
Stage IA OR stage IIA without bulky disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Frank G. Keller, MD | Mary Babb Randolph Cancer Center at West Virginia University Hospitals |
Study ID Numbers: | CDR0000459962, COG-AHOD0431 |
Study First Received: | March 9, 2006 |
Last Updated: | January 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00302003 |
Health Authority: | United States: Federal Government |
stage I childhood Hodgkin lymphoma stage II childhood Hodgkin lymphoma childhood lymphocyte depletion Hodgkin lymphoma |
childhood mixed cellularity Hodgkin lymphoma childhood nodular sclerosis Hodgkin lymphoma childhood favorable prognosis Hodgkin lymphoma |
Dexamethasone Prednisone Immunoproliferative Disorders Hodgkin's disease Hodgkin lymphoma, adult Vincristine Vinblastine Sclerosis Cyclophosphamide Etoposide phosphate Doxorubicin Lymphatic Diseases |
Ifosfamide Vinorelbine Cisplatin Hodgkin lymphoma, childhood Lymphoproliferative Disorders Etoposide Lymphoma Hodgkin Disease Cytarabine Dexamethasone acetate Isophosphamide mustard |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Antibiotics, Antineoplastic Hormones Therapeutic Uses Alkylating Agents Neoplasms by Histologic Type |
Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Gastrointestinal Agents Antimitotic Agents Immunosuppressive Agents Antiviral Agents Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Peripheral Nervous System Agents |