Treatment of Localized Low Grade Lymphomas | NCT00536458

Studies
Treatment of Localized Low Grade Lymphomas

NCT00536458

Sponsor

French Innovative Leukemia Organisation

Status

Completed

Last Update Posted

Nov 1, 2007Estimated

Enrollment

132Actual

Phase

Phase 3

Conditions

Lymphoma, Low-Grade

Interventions

radiotherapy
MINI CHEP

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1999

Primary Completion Date

Not provided

Completion Date

Dec 2006Actual

First Submitted Date

Sep 26, 2007

First Submission Date that Met QC Criteria

Sep 26, 2007

First Posted Date

Sep 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2007

Last Update Posted Date

Nov 1, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
radiotherapy	Experimental	minichep + radiotherapy	Procedure: radiotherapy
B	Active Comparator	MINI CHEP	Drug: MINI CHEP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radiotherapy	Procedure	mini chep+ radiotherapy	radiotherapy
MINI CHEP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
failure free survival at 5 years		5 years

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Low grade lymphoma defined according to the Ann Arbor classification
localized

Exclusion Criteria:

Subjects unable to signed informed consent
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
eric DECONINCK, MD PhD	French Innovative Leukemia Organisation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Regional university hospital		Besançon		25000	France

Condition Browse Module

MeSH Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
GOELAMS 01 02
GOELNH LOGLOC