Clinical trial NCT01156259: 30Gy Versus 40Gy Involved-field Radiotherapy for Localized Diffuse Large B Cell Lymphoma Achieving CR After Chemotherapy
Official title: Phase 3 Study of 30Gy Versus 40Gy Involved-field Radiotherapy in Localized Diffuse Large B Cell Lymphoma Achieving CR After Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lymphoma, Large B-Cell, Diffuse
Keywords: B cell cll/lymphoma, human
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Sun Yat-sen University
First posted: 2010-07-02
Enrollment: 400
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: disease free survival
timeFrame: five years
Secondary outcomes:
measure: overall survival
timeFrame: five years
measure: acute treatment toxicity
timeFrame: up to 16 weeks
measure: late treatment toxicity
timeFrame: five years
measure: treatment failure type
timeFrame: five years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Yexiong Li, MD
role: STUDY_DIRECTOR
References: