Phase III Study of Treatment of Localized Lymphomas: Radiotherapy Versus Radio-Chemotherapie
18 Years
79 Years
Both
Lymphoma, Low-Grade
Trial Information
Phase III Study of Treatment of Localized Lymphomas: Radiotherapy Versus Radio-Chemotherapie
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
Inclusion Criteria:
- Low grade lymphoma defined according to the Ann Arbor classification
- localized
Exclusion Criteria:
- Subjects unable to signed informed consent
- Pregnancy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
failure free survival at 5 years
Outcome Time Frame:
5 years
Principal Investigator
eric DECONINCK, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
01 02
NCT ID:
NCT00536458
Start Date:
March 1999
Completion Date:
December 2006
Related Keywords:
- Lymphoma, Low-Grade
- localized low grade lymphoma
- Chemotherapy
- Radiotherapy
- Molecular analyses
- primary
- Lymphoma
- Lymphoma, Non-Hodgkin
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