Treatment of Localized Low Grade Lymphomas

This study has been completed.
Sponsor:
Information provided by:
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:
NCT00536458
First received: September 26, 2007
Last updated: October 31, 2007
Last verified: September 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study of Treatment of Localized Lymphomas: Radiotherapy Versus Radio-Chemotherapie

Resource links provided by NLM:


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
Experimental: radiotherapy
minichep + radiotherapy
Procedure: radiotherapy
mini chep+ radiotherapy
Active Comparator: B
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00536458     History of Changes
Other Study ID Numbers: 01 02, GOELAMS 01 02, GOELNH LOGLOC
Study First Received: September 26, 2007
Last Updated: October 31, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014