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Treatment of Localized Low Grade Lymphomas

NCT ID: NCT00536458

Last Updated: 2007-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-03-31

Study Completion Date

2006-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Lymphoma, Low-Grade

Keywords

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localized low grade lymphoma Chemotherapy Radiotherapy Molecular analyses primary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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radiotherapy

minichep + radiotherapy

Group Type EXPERIMENTAL

radiotherapy

Intervention Type PROCEDURE

mini chep+ radiotherapy

B

MINI CHEP

Group Type ACTIVE_COMPARATOR

MINI CHEP

Intervention Type DRUG

chemotherapy minichep 6 courses

Interventions

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radiotherapy

mini chep+ radiotherapy

Intervention Type PROCEDURE

MINI CHEP

chemotherapy minichep 6 courses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Subjects unable to signed informed consent
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French Innovative Leukemia Organisation

OTHER

Sponsor Role lead

Principal Investigators

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eric DECONINCK, MD PhD

Role: PRINCIPAL_INVESTIGATOR

French Innovative Leukemia Organisation

Locations

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Regional university hospital

Besançon, , France

Site Status

Countries

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France

Other Identifiers

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GOELAMS 01 02

Identifier Type: -

Identifier Source: secondary_id

GOELNH LOGLOC

Identifier Type: -

Identifier Source: secondary_id

01 02

Identifier Type: -

Identifier Source: org_study_id