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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2010 by Chinese Academy of Medical Sciences
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, B-Cell
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014