NCT02803840

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at P25-P50 for phase_2 lymphoma

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
Last Updated

June 17, 2016

Status Verified

June 1, 2016

Enrollment Period

4.9 years

First QC Date

June 9, 2016

Last Update Submit

June 16, 2016

Conditions

Lymphoma

Keywords

Large B-CellDiffuse

Outcome Measures

Primary Outcomes (1)

  • Response rate

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

    Clinical response up to 21 days after treatment

Secondary Outcomes (1)

  • Quality of life according to the EORTC QLQ-C30 questionnaire

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

Study Arms (1)

Experimental

OTHER

DLBCL patients with indication for palliative radiotherapy

Radiation: Low-dose radiotherapy

Interventions

Low-dose radiotherapyRADIATION

2 x 2 Gy on symptomatic sites only

Also known as: LDRT
Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro di Riferimento Oncologico

Aviano, Pordenone, 33081, Italy

RECRUITING

MeSH Terms

Conditions

Lymphoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Carlo Furlan, MD

    Centro di Riferimento Oncologico - Aviano

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Furlan, MD

CONTACT

+390434659081cfurlan@cro.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2016

First Posted

June 17, 2016

Study Start

July 1, 2011

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 17, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)