Treatment of Aggressive Localized Lymphoma

Phase 3TerminatedNCT00841945

French Innovative Leukemia Organisation334 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

334

Conditions

B Cell Lymphoma

Interventions

rituximabDRUG

RITUXIMAB 375 MG/M² IV DAY 1 or each course

doxorubicinDRUG

doxorubicin 50 mg / m² iv day 1 of each course

vincristineDRUG

VINCRISTINE 1?4 MG/M² IV ON DAY 1

prednisone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Regional university hospital

Rennes, France

Outcomes

Primary Outcomes

Event Free Survival (EFS) and Progression Free Survival (PFS)

Time frame: EFS PFS one year after treatment

Secondary Outcomes

Pet-scan

Time frame: pronostic impact of Pet-scan

radiotherapy

Time frame: Toxicity of the radiotherapy

Data from ClinicalTrials.gov

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