Treatment of Localized Low Grade Lymphomas - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 26, 2007

Last Updated Date

October 31, 2007

Start Date ^†

March 1999

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00536458 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Treatment of Localized Low Grade Lymphomas

Official Title ^†

Phase III Study of Treatment of Localized Lymphomas: Radiotherapy Versus Radio-Chemotherapie

Brief Summary

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

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

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Lymphoma, Low-Grade

Intervention ^†

Procedure: radiotherapy
Drug: MINI CHEP

Study Arms / Comparison Groups

Experimental: minichep + radiotherapy
Active Comparator: MINI CHEP

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

132

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Low grade lymphoma defined according to the Ann Arbor classification
localized

Exclusion Criteria:

Subjects unable to signed informed consent
Pregnancy

Gender

Both

Ages

18 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

France

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00536458

Responsible Party

Secondary IDs ^††

GOELAMS 01 02, GOELNH LOGLOC

Study Sponsor ^†

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

Collaborators ^††

Investigators ^†

Principal Investigator:

eric DECONINCK, MD PhD

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

Verification Date

September 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.