30Gy Versus 40Gy Involved-field Radiotherapy for Localized Diffuse Large B Cell Lymphoma Achieving CR After Chemotherapy
This study is currently recruiting participants.
Verified April 2010 by Chinese Academy of Medical Sciences
Sponsor:
Chinese Academy of Medical Sciences
Collaborator:
Sun Yat-sen University
Information provided by:
Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01156259
First received: June 29, 2010
Last updated: July 1, 2010
Last verified: April 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Large B-Cell, Diffuse |
Radiation: 3D-CRT based Involved Field Radiotherapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 3 Study of 30Gy Versus 40Gy Involved-field Radiotherapy in Localized Diffuse Large B Cell Lymphoma Achieving CR After Chemotherapy |
Resource links provided by NLM:
Further study details as provided by Chinese Academy of Medical Sciences:
Primary Outcome Measures:
- disease free survival [ Time Frame: five years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- overall survival [ Time Frame: five years ] [ Designated as safety issue: No ]
- acute treatment toxicity [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
- late treatment toxicity [ Time Frame: five years ] [ Designated as safety issue: No ]
- treatment failure type [ Time Frame: five years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 30 Gy |
Radiation: 3D-CRT based Involved Field Radiotherapy
CT simulation, 3D-CRT or IMRT techniques, Involved Field Radiotherapy of 30Gy
|
| Active Comparator: 40 Gy |
Radiation: 3D-CRT based Involved Field Radiotherapy
CT simulation, 3D-CRT or IMRT techniques, Involved Field Radiotherapy of 40Gy
|
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| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156259
Contacts
| Contact: YeXiong Li, MD | 8610-87788860 | yexiong3@yahoo.com.cn |
| Contact: Shunan Qi, MD | 8610-87725547 | qishunan@yahoo.cn |
Locations
| China, Beijing | |
| Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting |
| Beijing, Beijing, China, 100021 | |
| Contact: Shunan qi, MD 8610-87725547 qishunan@yahoo.cn | |
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Sun Yat-sen University
Investigators
| Study Director: | Yexiong Li, MD | Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College |
More Information
No publications provided
| Responsible Party: | Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College |
| ClinicalTrials.gov Identifier: | NCT01156259 History of Changes |
| Other Study ID Numbers: | CH-LYM-004 |
| Study First Received: | June 29, 2010 |
| Last Updated: | July 1, 2010 |
| Health Authority: | China: Federal Institute for Drugs and Medical Devices |
Keywords provided by Chinese Academy of Medical Sciences:
|
B cell cll/lymphoma, human |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
ClinicalTrials.gov processed this record on May 22, 2013