Lymphoma, Large B-Cell, Diffuse
Conditions
Keywords
B cell cll/lymphoma, human
Brief summary
The purpose of this study is to determine whether 30Gy Involved-field Radiotherapy (IFRT) is as effective as 40Gy in the treatment of localized Diffused Large B cell Lymphoma (DLBCL) when completing CR after chemotherapy.
Detailed description
The best proper doses of IFRT in combined modality treatments (CMT) for localized DLBCL is still undetermined. Existing treatment guidelines recommend 40Gy or above as the standard treatment dosage. However, there were large-scaled clinical trials implying smaller doses such as 30Gy may be equivalent effective. Lowering radiation doses can decrease treatment toxicities and radiotherapy-induced diseases, which has been conformed by HD13 study for Hodgkin's Lymphoma. It may even retain the truth when modern era radiation techniques are involved and especially in patients achieving CR after chemotherapy. A comprehensive, prospective dose-comparing study is needed.
Interventions
RADIATION3D-CRT based Involved Field Radiotherapy
CT simulation, 3D-CRT or IMRT techniques, Involved Field Radiotherapy of 30Gy
Sponsors
Sun Yat-sen University
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* biopsy-proved Diffuse Large B cell lymphoma * nonbulky stage I, nonbulky stage IE, nonbulky stage II, or nonbulky stage IIE disease(Bulky disease was defined as a mass 10 cm or more in maximal diameter) according to Ann Arbor Staging * provide written informed consent * Complete regression after chemotherapy * Considerable to CT simulation and 3D CRT or IMRT * Performance status 0-2 WHO criteria；life expectation\>6 months * negative for human immunodeficiency virus syndrome (HIV) * Minimal staging included chest radiograph, computed tomography of the abdomen and pelvis, and single percutaneous bone marrow biopsy and blood studies
Exclusion criteria
* primary mediastinal large B cell lymphoma * dermatological lymphoma * testicular lymphoma * primary central nerve system lymphoma * prior RT * history of low-grade lymphoma congestive * history of heart failure (CHF; New York Heart Association \[NYHA\] classifications III-IV), history of neoplasm (adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix were allowed), abnormal liver function tests (aminotransferases and alkaline phosphatase \> 2.5 times the upper limit of normal, bilirubin \> 50 ), renal insufficiency (serum creatinine \> 300 ), and patients with any serious medical or psychiatric illness that would prevent informed consent or completion of protocol-prescribed treatment and follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease free survival | five years |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | five years |
| acute treatment toxicity | up to 16 weeks |
| late treatment toxicity | five years |
| treatment failure type | five years |
Countries
China
Contacts
Primary ContactYeXiong Li, MD
Backup ContactShunan Qi, MD
Outcome results
None listed