Back to results

Treatment of Localized Low Grade Lymphomas

Primary Purpose

Lymphoma, Low-Grade

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

radiotherapy

MINI CHEP

About this trial

This is an interventional treatment trial for Lymphoma, Low-Grade focused on measuring localized low grade lymphoma, Chemotherapy, Radiotherapy, Molecular analyses, primary

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Low grade lymphoma defined according to the Ann Arbor classification
localized

Exclusion Criteria:

Subjects unable to signed informed consent
Pregnancy

Sites / Locations

Regional university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

radiotherapy

Arm Description

minichep + radiotherapy

MINI CHEP

Outcomes

Primary Outcome Measures

failure free survival at 5 years

Secondary Outcome Measures

overall survival at 5 years

response rates at the end of the treatment

prognstic value of molecular analyses in blood and marrow

Full Information

NCT ID

NCT00536458

First Posted

September 26, 2007

Last Updated

October 31, 2007

Sponsor

French Innovative Leukemia Organisation

1. Study Identification

Unique Protocol Identification Number

NCT00536458

Brief Title

Treatment of Localized Low Grade Lymphomas

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2007

Overall Recruitment Status

Completed

Study Start Date

March 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

French Innovative Leukemia Organisation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Low-Grade

Keywords

localized low grade lymphoma, Chemotherapy, Radiotherapy, Molecular analyses, primary

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

132 (Actual)

8. Arms, Groups, and Interventions

Arm Title

radiotherapy

Arm Type

Experimental

Arm Description

minichep + radiotherapy

Arm Title

Arm Type

Active Comparator

Arm Description

MINI CHEP

Intervention Type

Procedure

Intervention Name(s)

radiotherapy

Intervention Description

mini chep+ radiotherapy

Intervention Type

Drug

Intervention Name(s)

MINI CHEP

Intervention Description

chemotherapy minichep 6 courses

Primary Outcome Measure Information:

Title

failure free survival at 5 years

Time Frame

5 years

Secondary Outcome Measure Information:

Title

overall survival at 5 years

Time Frame

5 years

Title

response rates at the end of the treatment

Time Frame

6 months

Title

prognstic value of molecular analyses in blood and marrow

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Low grade lymphoma defined according to the Ann Arbor classification localized Exclusion Criteria: Subjects unable to signed informed consent Pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

eric DECONINCK, MD PhD

Organizational Affiliation

French Innovative Leukemia Organisation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Regional university hospital

City

Besancon

ZIP/Postal Code

25000

Country

France

12. IPD Sharing Statement

Learn more about this trial

Treatment of Localized Low Grade Lymphomas

We'll reach out to this number within 24 hrs