Low-dose Radiotherapy for Diffuse Large B-cell Lymphoma

Lymphoma Clinical Trial

Official title:

A Phase II Trial of Low-Dose Radiotherapy for the Palliation of Patients With Diffuse Large B-cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02803840
• Other study ID #: CRO-2011-14
• Status: Recruiting
• Phase: Phase 2
• First received: June 9, 2016
• Last updated: June 16, 2016
• Start date: July 2011
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Centro di Riferimento Oncologico - Aviano
• Contact: Carlo Furlan, MD
• Phone: +390434659081
• Email: cfurlan[@]cro.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Patients with Diffuse Large B-cell Lymphoma with indication for palliative radiotherapy are treated with low-dose radiation (2 x 2 Gy) to the symptomatic sites only. The primary endpoint of the study is the response rate and Quality of Life of the patients (QoL).

Description:

Response is planned at 21-day after completion of the treatment. Response assessment is based on the standard definitions of the World Health Organization using complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) as response assessment criteria. The efficacy of the treatment consisted of a reduction greater than 50% of the maximum diameter of the radiated mass (PR + CR). QoL is evaluated using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 3.0 version questionnaire. The QLQ-C30 questionnaire is self administered to the patients at baseline and at 21 days after treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with histologically proven diagnosis of DLBCL with indication for palliative radiotherapy

Exclusion Criteria:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Radiation:
• Low-dose radiotherapy
2 x 2 Gy on symptomatic sites only

Locations

Country	Name	City	State
Italy	Centro di Riferimento Oncologico	Aviano	Pordenone

Sponsors (1)

Lead Sponsor	Collaborator
Centro di Riferimento Oncologico - Aviano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Clinical response is defined as reduction > 50% of maximum diameter of the radiated lesion	Clinical response up to 21 days after treatment	No
Secondary	Quality of life according to the EORTC QLQ-C30 questionnaire		The QLQ-C30 questionnaire is administered at baseline and at 21 days after treatment	No