Back to results30Gy Versus 40Gy Involved-field Radiotherapy for Localized Diffuse Large B Cell Lymphoma Achieving CR After Chemotherapy
Primary Purpose
Lymphoma, Large B-Cell, Diffuse
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
3D-CRT based Involved Field Radiotherapy
3D-CRT based Involved Field Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse focused on measuring B cell cll/lymphoma, human
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
Sites / Locations
- Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
30 Gy
40 Gy
Arm Description
Outcomes
Primary Outcome Measures
disease free survival
Secondary Outcome Measures
overall survival
acute treatment toxicity
late treatment toxicity
treatment failure type
Full Information
NCT ID
NCT01156259
First Posted
June 29, 2010
Last Updated
July 1, 2010
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT01156259
Brief Title
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
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large B-Cell, Diffuse
Keywords
B cell cll/lymphoma, human
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
30 Gy
Arm Type
Experimental
Arm Title
40 Gy
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
3D-CRT based Involved Field Radiotherapy
Intervention Description
CT simulation, 3D-CRT or IMRT techniques, Involved Field Radiotherapy of 30Gy
Intervention Type
Radiation
Intervention Name(s)
3D-CRT based Involved Field Radiotherapy
Intervention Description
CT simulation, 3D-CRT or IMRT techniques, Involved Field Radiotherapy of 40Gy
Primary Outcome Measure Information:
Title
disease free survival
Time Frame
five years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
five years
Title
acute treatment toxicity
Time Frame
up to 16 weeks
Title
late treatment toxicity
Time Frame
five years
Title
treatment failure type
Time Frame
five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YeXiong Li, MD
Phone
8610-87788860
Email
yexiong3@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Shunan Qi, MD
Phone
8610-87725547
Email
qishunan@yahoo.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yexiong Li, MD
Organizational Affiliation
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Official's Role
Study Director
Facility Information:
Facility Name
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shunan qi, MD
Phone
8610-87725547
Email
qishunan@yahoo.cn
12. IPD Sharing Statement
Learn more about this trial
30Gy Versus 40Gy Involved-field Radiotherapy for Localized Diffuse Large B Cell Lymphoma Achieving CR After Chemotherapy
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