This Trial is a Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas (IELSG33)
This study has been terminated.
(due to slow accrual (only 1 patient entered))
Information provided by (Responsible Party):
International Extranodal Lymphoma Study Group (IELSG)
First received: January 18, 2011
Last updated: July 6, 2012
Last verified: July 2012
In this study, the investigators propose that the addition of rituximab will lower the risk of systemic and local relapses in patients with localized PBL. Patients will be treated with 6 cycles of RCHOP-14 or RCHOP-21. The administration of radiotherapy following chemotherapy is strongly recommended, based on the findings of the retrospective IELSG study, but will be at the discretion of the treating center.
Diffuse Large B Cell Lymphoma of the Breast.
||Observational Model: Cohort
Time Perspective: Prospective
||A Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas Treated With R-CHOP With or Without Radiotherapy
Primary Outcome Measures:
- local and CNS relapse rate
Secondary Outcome Measures:
- progression free survival [ Time Frame: 12-month ]
- overall survival [ Time Frame: 5-year ]
- overall, complete and partial response rates following RCHOP [ Time Frame: at the end of chemotherapy ]
| Study Start Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Previously untreated patients with localized DLBCL of the breast.
- historical or radiographic evidence of CNS metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement.
- pregnant or breast feeding patients. Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception.
- active infection requiring parental antibiotics.
- known HIV infection
No Contacts or Locations Provided
No publications provided
||International Extranodal Lymphoma Study Group (IELSG)
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 18, 2011
||July 6, 2012
||Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Immune System Diseases