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Low-dose Radiotherapy for Diffuse Large B-cell Lymphoma

Primary Purpose

Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Low-dose radiotherapy

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Large B-Cell, Diffuse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

None

Sites / Locations

Centro di Riferimento OncologicoRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Experimental

Arm Description

DLBCL patients with indication for palliative radiotherapy

Outcomes

Primary Outcome Measures

Response rate

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

Secondary Outcome Measures

Quality of life according to the EORTC QLQ-C30 questionnaire

Full Information

NCT ID

NCT02803840

First Posted

June 9, 2016

Last Updated

June 16, 2016

Sponsor

Centro di Riferimento Oncologico - Aviano

1. Study Identification

Unique Protocol Identification Number

NCT02803840

Brief Title

Low-dose Radiotherapy for Diffuse Large B-cell Lymphoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2011 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centro di Riferimento Oncologico - Aviano

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

Large B-Cell, Diffuse

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Other

Arm Description

DLBCL patients with indication for palliative radiotherapy

Intervention Type

Radiation

Intervention Name(s)

Low-dose radiotherapy

Other Intervention Name(s)

LDRT

Intervention Description

2 x 2 Gy on symptomatic sites only

Primary Outcome Measure Information:

Title

Response rate

Description

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

Time Frame

Clinical response up to 21 days after treatment

Secondary Outcome Measure Information:

Title

Quality of life according to the EORTC QLQ-C30 questionnaire

Time Frame

The QLQ-C30 questionnaire is administered at baseline and at 21 days after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with histologically proven diagnosis of DLBCL with indication for palliative radiotherapy Exclusion Criteria: None

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carlo Furlan, MD

Phone

+390434659081

cfurlan@cro.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlo Furlan, MD

Organizational Affiliation

Centro di Riferimento Oncologico - Aviano

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centro di Riferimento Oncologico

City

Aviano

State/Province

Pordenone

ZIP/Postal Code

33081

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carlo Furlan, Oncologist

Phone

+390434659081

cfurlan@cro.it

First Name & Middle Initial & Last Name & Degree

Daniela Quitadamo, Biologist

Phone

+390434659077

dquitadamo@cro.it

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Low-dose Radiotherapy for Diffuse Large B-cell Lymphoma

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