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Treatment of Localized Low Grade Lymphomas

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ClinicalTrials.gov Identifier: NCT00536458
Recruitment Status : Completed
First Posted : September 27, 2007
Last Update Posted : November 1, 2007
Information provided by:
French Innovative Leukemia Organisation

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

Condition or disease Intervention/treatment Phase
Lymphoma, Low-Grade Procedure: radiotherapy Drug: MINI CHEP Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
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
Study Start Date : March 1999
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: radiotherapy
minichep + radiotherapy
Procedure: radiotherapy
mini chep+ radiotherapy
Active Comparator: B
chemotherapy minichep 6 courses

Primary Outcome Measures :
  1. failure free survival at 5 years [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. overall survival at 5 years [ Time Frame: 5 years ]
  2. response rates at the end of the treatment [ Time Frame: 6 months ]
  3. prognstic value of molecular analyses in blood and marrow [ Time Frame: 6 months ]

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536458

Regional university hospital
Besancon, France, 25000
Sponsors and Collaborators
French Innovative Leukemia Organisation
Principal Investigator: eric DECONINCK, MD PhD French Innovative Leukemia Organisation

ClinicalTrials.gov Identifier: NCT00536458     History of Changes
Other Study ID Numbers: 01 02
First Posted: September 27, 2007    Key Record Dates
Last Update Posted: November 1, 2007
Last Verified: September 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