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Treatment of Localized Low Grade Lymphomas

This study has been completed.
Information provided by:
French Innovative Leukemia Organisation Identifier:
First received: September 26, 2007
Last updated: October 31, 2007
Last verified: September 2007
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
Intervention Model: Parallel Assignment
Masking: None (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 French Innovative Leukemia Organisation:

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
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


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00536458

Regional university hospital
Besancon, France, 25000
Sponsors and Collaborators
French Innovative Leukemia Organisation
Principal Investigator: eric DECONINCK, MD PhD French Innovative Leukemia Organisation
  More Information Identifier: NCT00536458     History of Changes
Other Study ID Numbers: 01 02
Study First Received: September 26, 2007
Last Updated: October 31, 2007

Keywords provided by French Innovative Leukemia Organisation:
localized low grade lymphoma
Molecular analyses

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on September 19, 2017