Treatment of Aggressive Localized Lymphoma

Phase 3

Terminated

• Conditions: B Cell Lymphoma
• Interventions: Drug: rituximab; Drug: doxorubicin; Drug: vincristine; Drug: prednisone; Procedure: radiotherapy

• Registration Number: NCT00841945
• Lead Sponsor: French Innovative Leukemia Organisation

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

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2009-02-11
• Study First Submitted QC: 2009-02-11
• Study First Posted: 2009-02-12
• Primary Completion: 2016-01
• Status Verified: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 334

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	radiotherapy	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
2	prednisone	Chemotherapy - 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone
1	rituximab	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
1	doxorubicin	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
1	vincristine	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
1	prednisone	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
2	rituximab	Chemotherapy - 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone
2	doxorubicin	Chemotherapy - 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone
2	vincristine	Chemotherapy - 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone

Primary Outcome Measures

Name	Time	Method
Event Free Survival (EFS) and Progression Free Survival (PFS)	EFS PFS one year after treatment

Secondary Outcome Measures

Name	Time	Method
Pet-scan	pronostic impact of Pet-scan
radiotherapy	Toxicity of the radiotherapy

Trial Locations

Locations (1)

Regional university hospital; 🇫🇷 Rennes, France