30Gy Versus 40Gy Involved-field Radiotherapy for Localized Diffuse Large B Cell Lymphoma Achieving CR After Chemotherapy

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown

Phase 3

Conditions

Lymphoma, Large B-Cell, Diffuse

Treatments

Radiation: 3D-CRT based Involved Field Radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01156259

CH-LYM-004

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

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