Low-dose Radiotherapy for Diffuse Large B-cell Lymphoma

Centro di Riferimento Oncologico - Aviano

Status and phase: Unknown; Phase 2

Conditions: Lymphoma

Treatments: Radiation: Low-dose radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02803840

CRO-2011-14

Details and patient eligibility

About

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).

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Experimental

Other group

Description:

DLBCL patients with indication for palliative radiotherapy

Treatment:

Radiation: Low-dose radiotherapy