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

Phase 3

• Conditions: Lymphoma, Large B-Cell, Diffuse
• Interventions: Radiation: 3D-CRT based Involved Field Radiotherapy

• Registration Number: NCT01156259
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Study Timeline

• Status Verified: 2010-04
• Study Start: 2010-04
• Study First Submitted: 2010-06-29
• Study First Submitted QC: 2010-07-01
• Last Update Submitted: 2010-07-01
• Study First Posted: 2010-07-02
• Last Update Posted: 2010-07-02
• Primary Completion: 2015-04
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30 Gy	3D-CRT based Involved Field Radiotherapy	-
40 Gy	3D-CRT based Involved Field Radiotherapy	-

Primary Outcome Measures

Name	Time	Method
disease free survival	five years

Secondary Outcome Measures

Name	Time	Method
treatment failure type	five years
overall survival	five years
acute treatment toxicity	up to 16 weeks
late treatment toxicity	five years

Trial Locations

Locations (1)

Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China