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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 3 Study of 30Gy Versus 40Gy Involved-field Radiotherapy in Localized Diffuse Large B Cell Lymphoma Achieving CR After Chemotherapy

Conditions
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Lymphoma, Large B-Cell, Diffuse

Intervention / Treatment
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* Radiation: 3D-CRT based Involved Field Radiotherapy
* Radiation: 3D-CRT based Involved Field Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 30 Gy<br> | Radiation: 3D-CRT based Involved Field Radiotherapy<br>* CT simulation, 3D-CRT or IMRT techniques, Involved Field Radiotherapy of 30Gy<br>|
| Active Comparator: 40 Gy<br> | Radiation: 3D-CRT based Involved Field Radiotherapy<br>* CT simulation, 3D-CRT or IMRT techniques, Involved Field Radiotherapy of 40Gy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  | five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | five years | 
| acute treatment toxicity |  | up to 16 weeks | 
| late treatment toxicity |  | five years | 
| treatment failure type |  | five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B cell cll/lymphoma, human