Treatment of Aggressive Localized Lymphoma

February 20, 2017 updated by: French Innovative Leukemia Organisation

Phase III Study of the Interest of Radiotherapy After 4 or 6 Cycles of CHOP 14 Rituximab Regimen of Chemotherapy , Patients With Agressive Localized Lymphoma

Prospective and multicentric Phase III study, evaluation of the interest of the radiotherapy after 4 or 6 cycles of CHOP 14 R regimen of chemotherapy , patients with agressive and localized B lymphoma , age 18 to 75 years.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

CHOP 14 R regimen of chemotherapy is a good standard in the treatment of agressive and localized B lymphoma.

Interest of the radiotheraphy

Study Type

Interventional

Enrollment (Actual)

334

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • Regional University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 and < 75 years
  • Diffuse B large cell lymphoma , CD 20+
  • Ann Arbor stage I or II withe a bulk <7 cm
  • stage i ou II confirmed by the PET-scan
  • No previously treated
  • HIV negative
  • Signed Informed consent

Exclusion Criteria:

  • Age< 18 and > 75 years
  • other type of lymphoma
  • CD20 negative
  • Ann Arbor stage >II or bulk > 7 cm
  • HIV positive
  • Contraindication to Rituximab use according to Sm PC
  • Containdication to antracyclin
  • cancer or history of cancer , excepted in situ cancer of the cervix or skin epithelioma
  • Refusal of sign the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1

Chemotherapy + Radiotherapy

- 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone

  • Radiotherapy 40 gray on initial nodes
Drug: rituximab
RITUXIMAB 375 MG/M² IV DAY 1 or each course
Other Names:
  • MABTHERA
Drug: doxorubicin
doxorubicin 50 mg / m² iv day 1 of each course
Other Names:
  • Adriblastine
Drug: vincristine
VINCRISTINE 1?4 MG/M² IV ON DAY 1
Other Names:
  • Oncovin
Drug: prednisone
Prednisone 40 mg/m² DAy 1 to day 5
Other Names:
  • solupred
Procedure: radiotherapy
radiotherapy : total dose = 40 GY (5 fractions by week)
Other Names:
  • no other name
Experimental: 2

Chemotherapy

- 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone
Drug: rituximab
RITUXIMAB 375 MG/M² IV DAY 1 or each course
Other Names:
  • MABTHERA
Drug: doxorubicin
doxorubicin 50 mg / m² iv day 1 of each course
Other Names:
  • Adriblastine
Drug: vincristine
VINCRISTINE 1?4 MG/M² IV ON DAY 1
Other Names:
  • Oncovin
Drug: prednisone
Prednisone 40 mg/m² DAy 1 to day 5
Other Names:
  • solupred

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event Free Survival (EFS) and Progression Free Survival (PFS)
Time Frame: EFS PFS one year after treatment
EFS PFS one year after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Pet-scan
Time Frame: pronostic impact of Pet-scan
pronostic impact of Pet-scan
radiotherapy
Time Frame: Toxicity of the radiotherapy
Toxicity of the radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Innovative Leukemia Organisation

Investigators

  • Principal Investigator: Thierry LAMY, MD PhD, French Innovative Leukemia Organisation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

February 11, 2009

First Submitted That Met QC Criteria

February 11, 2009

First Posted (Estimate)

February 12, 2009

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOELAMS 02 03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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