Treatment of Localized Low Grade Lymphomas

This study has been completed.

First Received: September 26, 2007 Last Updated: October 31, 2007 History of Changes

Sponsored by:	Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Information provided by:	Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:	NCT00536458

Purpose

To compare localiezd radiotherapy to localized radiotherapy followed by 6 cycles of chemotherapy in the treatment of localiezd low grade lymphoma

Condition	Intervention	Phase
Lymphoma, Low-Grade	Procedure: radiotherapy Drug: MINI CHEP	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase III Study of Treatment of Localized Lymphomas: Radiotherapy Versus Radio-Chemotherapie

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma Radiation Therapy

U.S. FDA Resources

Further study details as provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

Primary Outcome Measures:

failure free survival at 5 years [ Time Frame: 5 years ]

Secondary Outcome Measures:

overall survival at 5 years [ Time Frame: 5 years ]
response rates at the end of the treatment [ Time Frame: 6 months ]
prognstic value of molecular analyses in blood and marrow [ Time Frame: 6 months ]

Enrollment:	132
Study Start Date:	March 1999
Study Completion Date:	December 2006

Arms	Assigned Interventions
radiotherapy: Experimental minichep + radiotherapy	Procedure: radiotherapy mini chep+ radiotherapy
B: Active Comparator MINI CHEP	Drug: MINI CHEP chemotherapy minichep 6 courses

Detailed Description:

The standard treatment ol localized low grade lymphomas is Radiotherapy alone can offer long term remissions to some patients . No study have clearly demonstrated the interest of chemotherapy. The purpose of the study is to determine wether prednisone administrated after first line local radiotherapy (30 GY) can pre in the treatment of localized low grade lymphomas of adult patients

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Low grade lymphoma defined according to the Ann Arbor classification
localized

Exclusion Criteria:

Subjects unable to signed informed consent
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536458

Locations

France
Regional university hospital
besancon, France, 25000

Sponsors and Collaborators

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Investigators

Principal Investigator:

eric DECONINCK, MD PhD

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

More Information

No publications provided

Study ID Numbers:	01 02, GOELAMS 01 02, GOELNH LOGLOC
Study First Received:	September 26, 2007
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00536458 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

localized low grade lymphoma
Chemotherapy
Radiotherapy
Molecular analyses
primary

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on September 11, 2009