Clincosm LogoSign in Get a demo

Treatment of Aggressive Localized Lymphoma

Sponsor
French Innovative Leukemia Organisation (Other)
Overall Status
Terminated
CT.gov ID
NCT00841945
Collaborator
(none)
334
Enrollment
1
Location
2
Arms
142.1
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
334 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Apr 1, 2005
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Feb 1, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Event Free Survival (EFS) and Progression Free Survival (PFS) [EFS PFS one year after treatment]

    Secondary Outcome Measures

    1. Pet-scan [pronostic impact of Pet-scan]

    2. radiotherapy [Toxicity of the radiotherapy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regional university hospital Rennes France 35033

    Sponsors and Collaborators

    • French Innovative Leukemia Organisation

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    French Innovative Leukemia Organisation
    ClinicalTrials.gov Identifier:
    NCT00841945
    Other Study ID Numbers:
    • GOELAMS 02 03
    First Posted:
    Feb 12, 2009
    Last Update Posted:
    Feb 23, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by French Innovative Leukemia Organisation
    Diffuse B larg cell lymphoma
    Chemotherapy
    Radiotherapy
    Additional relevant MeSH terms:
    Lymphoma
    Prednisone
    Rituximab
    Doxorubicin
    Vincristine

    Study Results

    No Results Posted as of Feb 23, 2017