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Completed

NCT Number: NCT00536458

Treatment of Localized Low Grade Lymphomas

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

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Key information

Conditions

Lymphoma, Low-Grade Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Regional university hospital

Besançon, 25000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Subjects unable to signed informed consent
  • Pregnancy

Treatment and study plan

Radiotherapy

Procedure

mini chep+ radiotherapy

MINI CHEP

Drug

chemotherapy minichep 6 courses

Primary outcomes

  1. failure free survival at 5 years

    Time frame: 5 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

French Innovative Leukemia Organisation

Other

Registry information

Official study title

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

Important dates

Study start
1999
Study completion
2006
First posted
Sep 27, 2007
Registry last updated
Nov 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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