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

Phase 3 Study of 30Gy Versus 40Gy Involved-field Radiotherapy in Localized Diffuse Large B Cell Lymphoma Achieving CR After Chemotherapy

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.

Study Overview

• Status: Unknown
• Conditions: Lymphoma, Large B-Cell, Diffuse
• Intervention / Treatment: Radiation: 3D-CRT based Involved Field Radiotherapy; Radiation: 3D-CRT based Involved Field Radiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: YeXiong Li, MD; Phone Number: 8610-87788860; Email: yexiong3@yahoo.com.cn
• Study Contact Backup: Name: Shunan qi, MD; Phone Number: 8610-87725547; Email: qishunan@yahoo.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
      • Contact: Shunan qi, MD; Phone Number: 8610-87725547; Email: qishunan@yahoo.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 30 Gy	Radiation: 3D-CRT based Involved Field Radiotherapy; CT simulation, 3D-CRT or IMRT techniques, Involved Field Radiotherapy of 30Gy; Radiation: 3D-CRT based Involved Field Radiotherapy; CT simulation, 3D-CRT or IMRT techniques, Involved Field Radiotherapy of 40Gy
Active Comparator: 40 Gy	Radiation: 3D-CRT based Involved Field Radiotherapy; CT simulation, 3D-CRT or IMRT techniques, Involved Field Radiotherapy of 30Gy; Radiation: 3D-CRT based Involved Field Radiotherapy; CT simulation, 3D-CRT or IMRT techniques, Involved Field Radiotherapy of 40Gy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
disease free survival	five years

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	five years
acute treatment toxicity	up to 16 weeks
late treatment toxicity	five years
treatment failure type	five years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): May 1, 2015

Study Registration Dates

• First Submitted: June 29, 2010
• First Submitted That Met QC Criteria: July 1, 2010
• First Posted (Estimate): July 2, 2010

Study Record Updates

• Last Update Posted (Estimate): July 2, 2010
• Last Update Submitted That Met QC Criteria: July 1, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: B cell cll/lymphoma, human
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: CH-LYM-004