Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin's Disease
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| First Received Date ICMJE | April 5, 2005 | ||||||||
| Last Updated Date | August 3, 2012 | ||||||||
| Start Date ICMJE | January 2006 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
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| Change History | Complete list of historical versions of study NCT00107198 on ClinicalTrials.gov Archive Site | ||||||||
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| Descriptive Information | |||||||||
| Brief Title ICMJE | Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin's Disease | ||||||||
| Official Title ICMJE | Treatment of Children With Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD) | ||||||||
| Brief Summary | RATIONALE: Surgery may be an effective treatment for lymphocyte predominant Hodgkin's disease. Drugs used in chemotherapy, such as doxorubicin, vincristine, prednisone, and cyclophosphamide, 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) with or without radiation therapy may kill more cancer cells. PURPOSE: This clinical trial is studying how well surgery and/or combination chemotherapy with or without radiation therapy or observation only work in treating young patients with newly diagnosed stage I or stage II lymphocyte predominant Hodgkin's disease. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter, pilot study. Patients are stratified according to level of surgical resection and disease stage (completely resected stage I disease vs incompletely resected stage I disease or stage II disease). Patients with stage IA disease who underwent confirmed complete resection of a single involved lymph node at diagnosis undergo observation only*. Patients with stage IA disease who underwent possible complete resection of a single involved lymph node at diagnosis undergo imaging at 6-7 weeks after surgery. Patients with a confirmed complete resection by imaging undergo observation only*. Patients who do not demonstrate complete resection by imaging proceed to combination chemotherapy with or without radiotherapy. Patients with stage IA disease who underwent a fine needle aspiration of a single involved lymph node OR an incomplete resection of a single involved lymph node at diagnosis may undergo a second surgery to achieve complete resection. Patients who undergo complete resection during the second surgery undergo imaging at 6-7 weeks after surgery. Patients with a confirmed complete resection by imaging undergo observation only*. Patients who do not undergo a second surgery OR do not achieve complete resection with the second surgery proceed to combination chemotherapy with or without radiotherapy. Patients with stage IA disease with involvement of more than 1 lymph node OR stage IIA disease proceed directly to combination chemotherapy with or without radiotherapy. NOTE: *Patients with recurrent disease after observation only undergo biopsy and restaging and then proceed to combination chemotherapy with or without radiotherapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, annually for 5 years, and then every 5 years for 10 years. PROJECTED ACCRUAL: A total of 150 patients (at least 50 for stratum I and 100 for stratum II) will be accrued for this study within 5 years. |
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| Study Type ICMJE | Interventional | ||||||||
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| Study Design ICMJE | Primary Purpose: Treatment | ||||||||
| Condition ICMJE | Lymphoma | ||||||||
| Intervention ICMJE |
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| Study Arm (s) | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 150 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Gender | Both | ||||||||
| Ages | up to 21 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States, Australia, Canada, New Zealand, Puerto Rico | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00107198 | ||||||||
| Other Study ID Numbers ICMJE | CDR0000419921, COG-AHOD03P1 | ||||||||
| Has Data Monitoring Committee | |||||||||
| Responsible Party | |||||||||
| Study Sponsor ICMJE | Children's Oncology Group | ||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | November 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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