Treatment of Localized Low Grade Lymphomas

October 31, 2007 updated by: French Innovative Leukemia Organisation

Phase III Study of Treatment of Localized Lymphomas: Radiotherapy Versus Radio-Chemotherapie

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

132

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25000
        • Regional University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Low grade lymphoma defined according to the Ann Arbor classification
  • localized

Exclusion Criteria:

  • Subjects unable to signed informed consent
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: radiotherapy
minichep + radiotherapy
Procedure: radiotherapy
mini chep+ radiotherapy
ACTIVE_COMPARATOR: B
MINI CHEP
Drug: MINI CHEP
chemotherapy minichep 6 courses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
failure free survival at 5 years
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival at 5 years
Time Frame: 5 years
5 years
response rates at the end of the treatment
Time Frame: 6 months
6 months
prognstic value of molecular analyses in blood and marrow
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Innovative Leukemia Organisation

Investigators

  • Principal Investigator: eric DECONINCK, MD PhD, French Innovative Leukemia Organisation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1999

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

September 26, 2007

First Submitted That Met QC Criteria

September 26, 2007

First Posted (ESTIMATE)

September 27, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2007

Last Update Submitted That Met QC Criteria

October 31, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 02
  • GOELAMS 01 02
  • GOELNH LOGLOC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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