Treatment of Localized Low Grade Lymphomas

Lymphoma, Low-Grade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00536458
• Other study ID #: 01 02
• Secondary ID: GOELAMS 01 02GOE
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2007
• Last updated: October 31, 2007
• Start date: March 1999
• Est. completion date: December 2006

Study information

• Verified date: September 2007
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• Low grade lymphoma defined according to the Ann Arbor classification

• localized

Exclusion Criteria:

• Subjects unable to signed informed consent

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Low-Grade
• Lymphoma, Non-Hodgkin

Intervention

Procedure:
• radiotherapy
mini chep+ radiotherapy

Drug:
• MINI CHEP
chemotherapy minichep 6 courses

Locations

Country	Name	City	State
France	Regional university hospital	Besancon

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	failure free survival at 5 years		5 years
Secondary	overall survival at 5 years		5 years
Secondary	response rates at the end of the treatment		6 months
Secondary	prognstic value of molecular analyses in blood and marrow		6 months