Lymphoma
Conditions
Keywords
Large B-Cell, Diffuse
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.
Interventions
RADIATIONLow-dose radiotherapy
2 x 2 Gy on symptomatic sites only
Sponsors
Centro di Riferimento Oncologico - Aviano
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histologically proven diagnosis of DLBCL with indication for palliative radiotherapy
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Quality of life according to the EORTC QLQ-C30 questionnaire | The QLQ-C30 questionnaire is administered at baseline and at 21 days after treatment |
Countries
Italy
Contacts
Primary ContactCarlo Furlan, MD
Outcome results
None listed