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

Lymphoma, Large B-Cell, Diffuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01156259
• Other study ID #: CH-LYM-004
• Status: Recruiting
• Phase: Phase 3
• First received: June 29, 2010
• Last updated: July 1, 2010
• Start date: April 2010
• Est. completion date: May 2015

Study information

• Verified date: April 2010
• Source: Chinese Academy of Medical Sciences
• Contact: YeXiong Li, MD
• Phone: 8610-87788860
• Email: yexiong3[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Radiation:
• 3D-CRT based Involved Field Radiotherapy
CT simulation, 3D-CRT or IMRT techniques, Involved Field Radiotherapy of 30Gy
• 3D-CRT based Involved Field Radiotherapy
CT simulation, 3D-CRT or IMRT techniques, Involved Field Radiotherapy of 40Gy

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival		five years	No
Secondary	overall survival		five years	No
Secondary	acute treatment toxicity		up to 16 weeks	No
Secondary	late treatment toxicity		five years	No
Secondary	treatment failure type		five years	No