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
Overview
- Phase
- Phase 3
- Intervention
- rituximab
- Conditions
- B Cell Lymphoma
- Sponsor
- French Innovative Leukemia Organisation
- Enrollment
- 334
- Locations
- 1
- Primary Endpoint
- Event Free Survival (EFS) and Progression Free Survival (PFS)
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
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
Investigators
Eligibility Criteria
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
Arms & Interventions
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
Intervention: rituximab
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
Intervention: doxorubicin
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
Intervention: vincristine
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
Intervention: prednisone
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
Intervention: radiotherapy
2
Chemotherapy - 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone
Intervention: rituximab
2
Chemotherapy - 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone
Intervention: doxorubicin
2
Chemotherapy - 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone
Intervention: vincristine
2
Chemotherapy - 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone
Intervention: prednisone
Outcomes
Primary Outcomes
Event Free Survival (EFS) and Progression Free Survival (PFS)
Time Frame: EFS PFS one year after treatment
Secondary Outcomes
- Pet-scan(pronostic impact of Pet-scan)
- radiotherapy(Toxicity of the radiotherapy)