Observation in Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma Treated on Clinical Trial CAN-NCIC-LY9

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Treatment for diffuse large B-cell non-Hodgkin's lymphoma may cause side effects and secondary cancers later in life. An observational study that evaluates patients after undergoing six courses of combination chemotherapy with or without rituximab and radiation therapy may help doctors predict a patient's response to this treatment and help plan the best treatment. PURPOSE: This observational study is evaluating patients with diffuse large B-cell non-Hodgkin's lymphoma to see how well treatment on clinical trial CAN-NCIC-LY9 works.

Detailed Description
-----------------
OBJECTIVES: Gain information on the long-term efficacy of 6 courses of CHOP (cyclophosphamide, doxorubicin hydrochloride, prednisone, and vincristine)-like chemotherapy with vs without rituximab (plus involved-field radiotherapy to primary bulky disease) in young patients with good-prognosis diffuse large B-cell non-Hodgkin's lymphoma treated on protocol CAN-NCIC-LY9. Gain information on late toxicities, including secondary neoplasm occurring in young good-prognosis patients treated on protocol CAN-NCIC-LY9. OUTLINE: This is a multicenter study. Patients successfully completing treatment on protocol CAN-NCIC-LY9 are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 667 patients will be accrued for this study.

Official Title
-----------------
Follow-up Observational Study of the Randomised Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma With CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab (IDEC-C2B8) [MINT]

Conditions
-----------------
Long-term Effects Secondary to Cancer Therapy in Adults, Lymphoma

Intervention / Treatment
-----------------
* Other: clinical observation
* Procedure: management of therapy complications


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Patients recruited for protocol CAN-NCIC-LY9 and evaluated in the first planned final analysis as of June 2005 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: clinical observation|nan|
|Procedure: management of therapy complications|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment failure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission rate |  |  | 
| Relapse rate |  |  | 
| Overall survival |  |  | 
| Tumor control |  |  | 
| Disease-free survival |  |  | 
| Time to progression |  |  | 
| Time to relapse |  |  | 
| Late toxicities, particularly organ function deficiencies (e.g., cardiomyopathies), infections, and secondary neoplasms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
long-term effects secondary to cancer therapy in adults, stage I adult diffuse large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma