Status:
UNKNOWN
30Gy Versus 40Gy Involved-field Radiotherapy for Localized Diffuse Large B Cell Lymphoma Achieving CR After Chemotherapy
Lead Sponsor:
Chinese Academy of Medical Sciences
Collaborating Sponsors:
Sun Yat-sen University
Conditions:
Lymphoma, Large B-Cell, Diffuse
Eligibility:
All Genders
15+ years
Phase:
PHASE3
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 C...
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. H...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2015
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01156259
Start Date
April 1 2010
End Date
May 1 2015
Last Update
July 2 2010
Active Locations (1)
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1
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021