NCT02803840

Low-dose Radiotherapy for Diffuse Large B-cell Lymphoma

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Centro di Riferimento Oncologico - Aviano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
RADIATION	Low-dose radiotherapy	2 x 2 Gy on symptomatic sites only

Timeline

• Start date: 2011-07-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-06-17
• Last updated: 2016-06-17

Locations

1 site across 1 country: Italy