Treatment of Localized Low Grade Lymphomas

• Sponsor: French Innovative Leukemia Organisation (Other)
• Overall Status: Completed
• CT.gov ID: NCT00536458
• Collaborator: (none)
• Enrollment: 132
• Location: 1
• Arms: 2
• Duration (Months): 93
• Patients Per Site Per Month: 1.4

Study Details

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

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 Design

• Study Type: Interventional
• 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: Mar 1, 1999
• Actual Study Completion Date: Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: radiotherapy minichep + radiotherapy	Procedure: radiotherapy; mini chep+ radiotherapy
Active Comparator: B MINI CHEP	Drug: MINI CHEP; chemotherapy minichep 6 courses

Outcome Measures

Primary Outcome Measures

1. failure free survival at 5 years [5 years]

Secondary Outcome Measures

1. overall survival at 5 years [5 years]

2. response rates at the end of the treatment [6 months]

3. prognstic value of molecular analyses in blood and marrow [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regional university hospital	Besancon		France	25000

Sponsors and Collaborators

• French Innovative Leukemia Organisation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00536458
• Other Study ID Numbers: 01 02; GOELAMS 01 02; GOELNH LOGLOC
• First Posted: Sep 27, 2007
• Last Update Posted: Nov 1, 2007
• Last Verified: Sep 1, 2007

• Keywords provided by , ,: localized low grade lymphoma; Chemotherapy; Radiotherapy; Molecular analyses; primary
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin

Study Results

No Results Posted as of Nov 1, 2007