NCT00536458

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 1999

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
7.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
Last Updated

November 1, 2007

Status Verified

September 1, 2007

First QC Date

September 26, 2007

Last Update Submit

October 31, 2007

Conditions

Lymphoma, Low-Grade

Keywords

localized low grade lymphomaChemotherapyRadiotherapyMolecular analysesprimary

Outcome Measures

Primary Outcomes (1)

  • failure free survival at 5 years

    5 years

Secondary Outcomes (3)

  • 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

    6 months

Study Arms (2)

radiotherapy

EXPERIMENTAL

minichep + radiotherapy

Procedure: radiotherapy

B

ACTIVE COMPARATOR

MINI CHEP

Drug: MINI CHEP

Interventions

radiotherapyPROCEDURE

mini chep+ radiotherapy

radiotherapy
MINI CHEPDRUG

chemotherapy minichep 6 courses

B

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Subjects unable to signed informed consent
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional university hospital

Besançon, 25000, France

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • eric DECONINCK, MD PhD

    French Innovative Leukemia Organisation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2007

First Posted

September 27, 2007

Study Start

March 1, 1999

Study Completion

December 1, 2006

Last Updated

November 1, 2007

Record last verified: 2007-09

Locations

FR(1)