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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.

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
NameTimeMethod
Response rateClinical response up to 21 days after treatment

Clinical response is defined as reduction \> 50% of maximum diameter of the radiated lesion

Secondary Outcome Measures
NameTimeMethod
Quality of life according to the EORTC QLQ-C30 questionnaireThe QLQ-C30 questionnaire is administered at baseline and at 21 days after treatment

Trial Locations

Locations (1)

Centro di Riferimento Oncologico

🇮🇹

Aviano, Pordenone, Italy

Centro di Riferimento Oncologico
🇮🇹Aviano, Pordenone, Italy
Carlo Furlan, Oncologist
Contact
+390434659081
cfurlan@cro.it
Daniela Quitadamo, Biologist
Contact
+390434659077
dquitadamo@cro.it

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