Low-dose Radiotherapy for Diffuse Large B-cell Lymphoma

June 16, 2016 updated by: Centro di Riferimento Oncologico - Aviano

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Recruiting
        • Centro di Riferimento Oncologico
        • Contact:
          • Carlo Furlan, Oncologist
          • Phone Number: +390434659081
          • Email: cfurlan@cro.it
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Experimental
DLBCL patients with indication for palliative radiotherapy
Radiation: Low-dose radiotherapy
2 x 2 Gy on symptomatic sites only
Other Names:
  • LDRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: Clinical response up to 21 days after treatment
Clinical response is defined as reduction > 50% of maximum diameter of the radiated lesion
Clinical response up to 21 days after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
The QLQ-C30 questionnaire is administered at baseline and at 21 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro di Riferimento Oncologico - Aviano

Investigators

  • Principal Investigator: Carlo Furlan, MD, Centro di Riferimento Oncologico - Aviano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

June 9, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Estimate)

June 17, 2016

Last Update Submitted That Met QC Criteria

June 16, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO-2011-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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