Treatment of Aggressive Localized Lymphoma

Sponsor
French Innovative Leukemia Organisation
Study ID
NCT00841945
Phase
PHASE3
Status
Terminated

Conditions

  • B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — DRUG
    RITUXIMAB 375 MG/M² IV DAY 1 or each course
  • doxorubicin — DRUG
    doxorubicin 50 mg / m² iv day 1 of each course
  • vincristine — DRUG
    VINCRISTINE 1?4 MG/M² IV ON DAY 1
  • prednisone — DRUG
    Prednisone 40 mg/m² DAy 1 to day 5
  • radiotherapy — PROCEDURE
    radiotherapy : total dose = 40 GY (5 fractions by week)

Study Details

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.

Key Dates

Start date
Apr 30, 2005
Status verified
Feb 2017
Primary completion
Jan 31, 2016
Completion
Feb 28, 2017

Study Design

Enrollment
334 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • Experimental: 2
    Chemotherapy \- 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone

Primary Outcome Measure

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

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