Phase III Study of the Interest of Radiotherapy After 4 or 6 Cycles of CHOP 14 Rituximab Regimen of Chemotherapy , Patients With Agressive Localized Lymphoma
18 Years
75 Years
Both
Localized Diffuse B Cell Lymphoma
Trial Information
Phase III Study of the Interest of Radiotherapy After 4 or 6 Cycles of CHOP 14 Rituximab Regimen of Chemotherapy , Patients With Agressive Localized Lymphoma
CHOP 14 R regimen of chemotherapy is a good standard in the treatment of agressive and
localized B lymphoma.
Interest of the radiotheraphy
Inclusion Criteria:
- Age > 18 and < 75 years
- Diffuse B large cell lymphoma , CD 20+
- Ann Arbor stage I or II withe a bulk <7 cm
- stage i ou II confirmed by the PET-scan
- No previously treated
- HIV negative
- Signed Informed consent
Exclusion Criteria:
- Age< 18 and > 75 years
- other type of lymphoma
- CD20 negative
- Ann Arbor stage >II or bulk > 7 cm
- HIV positive
- Contraindication to Rituximab use according to Sm PC
- Containdication to antracyclin
- cancer or history of cancer , excepted in situ cancer of the cervix or skin
epithelioma
- Refusal of sign the informed consent
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:
Event Free Survival (EFS) and Progression Free Survival (PFS)
Outcome Time Frame:
EFS PFS one year after treatment
Safety Issue:
Yes
Principal Investigator
Thierry LAMY, 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:
GOELAMS 02 03
NCT ID:
NCT00841945
Start Date:
April 2005
Completion Date:
June 2014
Related Keywords:
- Localized Diffuse B Cell Lymphoma
- Diffuse B larg cell lymphoma
- Chemotherapy
- Radiotherapy
- Lymphoma
- Lymphoma, B-Cell
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