This study aims; to assess the efficacy of shortened systemic chemotherapy in patients with completely excised CD20 positive Diffuse Large B-cell Lymphoma (DLBCL) with Ann Arbor Stage I or II.
Unlike the limited stage diffuse Large B-cell Lymphoma (DLBCL) treated with primary chemotherapy followed by radiotherapy, patients with stage I or II DLBCL would be treated with surgical resection followed by chemotherapy in this trial. While chemotherapy is the main treatment modality and radiotherapy becomes adjuvant treatment in the former treatment scheme, surgical resection will remove all the gross lesions and chemotherapy aims to remove all microscopic disease whichever exists in the latter treatment scheme. Currently, six cycles of chemotherapy is usually performed after surgery even without any residual lesion compared with three cycles of chemotherapy in the former treatment scheme which plays primary role in the treatment scheme. The investigators will investigate whether abbreviated 3 cycles of Rituximab Plus Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone (R-CHOP) immunochemotherapy following complete resection is an effective and safe treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
The R-CHOP treatment will continue up to 3 cycles with interval of 21 days: Each cycle consists of rituximab 375mg/m2 (iv, on day 1), cyclophosphamide 750 mg/m2 (iv, on day 1), doxorubicin 50mg/m2 (iv, on day 1), vincristine 1.4mg/m2 (iv, on day 1), and prednisolone 100mg (po, on day 1-5).
Asan Medical Center
Seoul, South Korea
Disease-free survival
Proportion of patients surviving 2 years after first R-CHOP chemotherapy with no relapse of DLBCL
Time frame: 2 years
Overall survival
proportion of patients surviving at 2 year after first cycle of R-CHOP chemotherapy regardless of relapse of DLBCL
Time frame: 2 years
any adverse events as a measure of safety and tolerability
The number of patients with adverse events will be measured during R-CHOP chemotherapy according to CTCAE version 3.0.
Time frame: from the first R-CHOP to 1 month after completion of R-CHOP
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