Spots Global Cancer Trial Database for PET Scans in Patients With Diffuse Large B-Cell Lymphoma Receiving Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone
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Trial Identification
Brief Title: PET Scans in Patients With Diffuse Large B-Cell Lymphoma Receiving Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone
Official Title: Prospective Evaluation of the Predictive Value of PET in Patients With Diffuse Large B-cell-lymphoma Under R-CHOP-14. A Multicenter Study
Study ID: NCT00544219
Conditions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
European Institute of Oncology, Milan, , Italy
Hirslanden Klinik Aarau, Aarau, , Switzerland
Kantonspital Aarau, Aarau, , Switzerland
Kantonsspital Baden, Baden, , Switzerland
Praxis Dr. Streit, Baden, , Switzerland
Saint Claraspital AG, Basel, , Switzerland
Universitaetsspital-Basel, Basel, , Switzerland
Oncology Institute of Southern Switzerland, Bellinzona, , Switzerland
Inselspital Bern, Bern, , Switzerland
Kantonsspital Bruderholz, Bruderholz, , Switzerland
Kantonsspital Graubuenden, Chur, , Switzerland
Hopital Cantonal Universitaire de Geneve, Geneva, , Switzerland
Kantonsspital Liestal, Liestal, , Switzerland
Kantonsspital Olten, Olten, , Switzerland
Praxis Dr. Beretta, Rheinfelden, , Switzerland
Kantonsspital - St. Gallen, St. Gallen, , Switzerland
Regionalspital, Thun, , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
UniversitaetsSpital Zuerich, Zurich, , Switzerland
Contact Details
Name: Christoph Mamot, MD
Affiliation: Kantonsspital Aarau
Role: STUDY_CHAIR
Name: Mario Bargetzi, MD
Affiliation: Kantonsspital Aarau
Role: STUDY_CHAIR
Name: Giovanni Martinelli, MD
Affiliation: European Institute of Oncology
Role: STUDY_CHAIR
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