PET Scans in Patients With Diffuse Large B-Cell Lymphoma Receiving Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone
- Conditions
- Lymphoma
- Interventions
- Biological: rituximabProcedure: positron emission tomography
- Registration Number
- NCT00544219
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Brief Summary
RATIONALE: Studying PET scans given to patients with cancer who are undergoing treatment may help doctors predict how patients will respond to treatment.
PURPOSE: This clinical trial is studying PET scans in patients with diffuse large B-cell lymphoma who are receiving rituximab together with cyclophosphamide, doxorubicin, vincristine, and prednisone.
- Detailed Description
OBJECTIVES:
Primary
* To evaluate if an early positive positron emission tomography (PET) scan after 2 courses of rituximab with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone can be used to identify a group of patients having a poor prognosis.
Secondary
* To compare modified PET/CT scan response criteria with revised standard response criteria.
* To evaluate, in a prospective manner, whether a proliferation-inducing ligand (APRIL) expression is a prognostic factor in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Rituximab IV alone is continued for an additional 2 courses after completion of the initial 6 courses.
Patients undergo positron emission tomography (PET) scan prior to and after completion of study therapy. Patients also undergo PET scan after course 2, and those with a positive PET result undergo an additional PET scan after course 4.
Previously collected tumor samples are analyzed for a proliferation-inducing ligand (APRIL) expression.
After completion of study treatment, patients are followed periodically for up to 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description R-Chop 14 cyclophosphamide Standard treatment R-Chop 14 rituximab Standard treatment R-Chop 14 positron emission tomography Standard treatment R-Chop 14 doxorubicin hydrochloride Standard treatment R-Chop 14 vincristine sulfate Standard treatment R-Chop 14 prednisone Standard treatment
- Primary Outcome Measures
Name Time Method Event-free survival at 2 years
- Secondary Outcome Measures
Name Time Method Event-free survival at 5 years Overall survival during follow-up at 2 and 5 years Objective response at 2 years Positron emission tomography (PET) results at 2 years Histological results of remaining PET-positive lesion(s) after treatment at 2 years
Trial Locations
- Locations (19)
Kantonspital Aarau
🇨🇭Aarau, Switzerland
Kantonsspital Bruderholz
🇨🇭Bruderholz, Switzerland
Kantonsspital Liestal
🇨🇭Liestal, Switzerland
UniversitaetsSpital Zuerich
🇨🇭Zurich, Switzerland
Kantonsspital Baden
🇨🇭Baden, Switzerland
Praxis Dr. Streit
🇨🇭Baden, Switzerland
Saint Claraspital AG
🇨🇭Basel, Switzerland
Universitaetsspital-Basel
🇨🇭Basel, Switzerland
Kantonsspital Graubuenden
🇨🇭Chur, Switzerland
Oncology Institute of Southern Switzerland
🇨🇭Bellinzona, Switzerland
Hopital Cantonal Universitaire de Geneve
🇨🇭Geneva, Switzerland
Kantonsspital Olten
🇨🇭Olten, Switzerland
Praxis Dr. Beretta
🇨🇭Rheinfelden, Switzerland
Regionalspital
🇨🇭Thun, Switzerland
Kantonsspital Winterthur
🇨🇭Winterthur, Switzerland
Hirslanden Klinik Aarau
🇨🇭Aarau, Switzerland
Inselspital Bern
🇨🇭Bern, Switzerland
European Institute of Oncology
🇮🇹Milan, Italy
Kantonsspital - St. Gallen
🇨🇭St. Gallen, Switzerland