Treatment of Aggressive Localized Lymphoma

Study Overview
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Brief Summary
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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.

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

Official Title
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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

Conditions
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B Cell Lymphoma

Intervention / Treatment
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* Drug: rituximab
* Drug: doxorubicin
* Drug: vincristine
* Drug: prednisone
* Procedure: radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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<br>* RITUXIMAB 375 MG/M² IV DAY 1 or each course<br>* Other names: MABTHERA;Drug: doxorubicin<br>* doxorubicin 50 mg / m² iv day 1 of each course<br>* Other names: Adriblastine;Drug: vincristine<br>* VINCRISTINE 1?4 MG/M² IV ON DAY 1<br>* Other names: Oncovin;Drug: prednisone<br>* Prednisone 40 mg/m² DAy 1 to day 5<br>* Other names: solupred;Procedure: radiotherapy<br>* radiotherapy : total dose = 40 GY (5 fractions by week)<br>* Other names: no other name;|
| Experimental: 2<br>Chemotherapy - 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone | Drug: rituximab<br>* RITUXIMAB 375 MG/M² IV DAY 1 or each course<br>* Other names: MABTHERA;Drug: doxorubicin<br>* doxorubicin 50 mg / m² iv day 1 of each course<br>* Other names: Adriblastine;Drug: vincristine<br>* VINCRISTINE 1?4 MG/M² IV ON DAY 1<br>* Other names: Oncovin;Drug: prednisone<br>* Prednisone 40 mg/m² DAy 1 to day 5<br>* Other names: solupred;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diffuse B larg cell lymphoma, Chemotherapy, Radiotherapy