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| Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00070018 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining chemotherapy with radiation therapy and monoclonal antibody therapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy and monoclonal antibody therapy works in treating patients with stage I or stage II non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|
Lymphoma |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: rituximab Drug: vincristine sulfate Drug: yttrium Y 90 ibritumomab tiuxetan Procedure: radiation therapy |
Phase II |
| MedlinePlus related topics: | Cancer Lymphoma |
| Drug Information available for: | Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Prednisone Vincristine sulfate Vincristine Rituximab Ibritumomab tiuxetan |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Evaluation of CHOP Plus Involved Field Radiotherapy Followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized, Aggressive Histologies of Non-Hodgkin Lymphoma, Phase II |
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2004 |
| Estimated Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 15 months.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes:
Stage I, IE, or non-bulky* stage II or IIE disease by Ann Arbor classification
Aggressive lymphomas must have at least 1 of the following adverse prognostic factors:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations![]() |
Show 59 Study Locations |
| Southwest Oncology Group |
| National Cancer Institute (NCI) |
| Investigator: | Thomas P. Miller, MD | University of Arizona |
| Investigator: | Oliver W. Press, MD, PhD | Fred Hutchinson Cancer Research Center |
| Investigator: | Baldassarre D. Stea, MD, PhD | University of Arizona |
| Investigator: | Louis S. Constine, MD | James P. Wilmot Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000329864, SWOG-S0313 |
| First Received: | October 3, 2003 |
| Last Updated: | November 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00070018 |
| Health Authority: | Unspecified |
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