Phase II Trial Investigating Tailoring First-Line Therapy For Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Mid-Treatment Positron Emission Tomography (PET) Scan Results
This is a phase II trial investigating tailoring first-line therapy for advanced stage
diffuse large B-cell NHL (DLBCL) based on a mid-treatment 18F-FDG- positron-emission
tomography (PET) scan result. More than half of all patients with DLBCL can be cured with
6-8 cycles of standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine,
prednisone). Patients who are not cured with R-CHOP have a very poor prognosis. This study
will assess whether patients who are likely to fail R-CHOP, as predicted by a mid-treatment
PET scan, can have an improved outcome if switched to a standard salvage regimen R-ICE
(rituximab, ifosfamide, carboplatin, etoposide).
Objectives:
- To assess the efficacy of tailoring first-line therapy based on a mid- treatment PET
scan result for patients with advanced stage DLBCL.
- To assess the progression-free survival (PFS) in patients with advanced stage DLBCL who
have a negative mid-treatment PET scan and receive standard therapy with six cycles of
CHOP-R and patients with a positive mid-treatment PET scan who receive four cycles of
CHOP-R followed by four cycles of R-ICE chemotherapy.
- To assess the overall survival (OS) in patients with advanced stage DLBCL who have a
negative mid-treatment PET scan and receive standard therapy with six cycles of CHOP-R
and patients with a positive mid-treatment PET scan who receive four cycles of CHOP-R
followed by four cycles of R-ICE chemotherapy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
efficacy
Laurie Sehn, MD
Principal Investigator
BC Cancer Agency - Vancouver Centre
Canada: Health Canada
PET in DLBCL
NCT00324467
August 2006
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