Low-dose Radiotherapy for Diffuse Large B-cell Lymphoma

Phase 2

• Conditions: Lymphoma

• Registration Number: NCT02803840
• Lead Sponsor: Centro di Riferimento Oncologico - Aviano

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2011-07
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-16
• Last Update Submitted: 2016-06-16
• Study First Posted: 2016-06-17
• Last Update Posted: 2016-06-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate	Clinical response up to 21 days after treatment	Clinical response is defined as reduction \> 50% of maximum diameter of the radiated lesion

Secondary Outcome Measures

Name	Time	Method
Quality of life according to the EORTC QLQ-C30 questionnaire	The QLQ-C30 questionnaire is administered at baseline and at 21 days after treatment

Trial Locations

Locations (1)

Centro di Riferimento Oncologico; 🇮🇹 Aviano, Pordenone, Italy