Evaluation of Splenic Irradiation in Chronic Lymphatic Leukemia

Withdrawn

• Conditions: Leukemia, Chronic Lymphatic
• Interventions: Radiation: splenic irradiation

• Registration Number: NCT02020109
• Lead Sponsor: Maastricht Radiation Oncology

Brief Summary

Retrospective evaluation on the effect of splenic irradiation on clinical and hematological response and toxicity in patients with chronic lymphatic leukaemia (CLL).

Detailed Description

The study will include patients with CLL treated with splenic irradiation in Maastro Clinic, Maastricht, The Netherlands, Maxima Medisch Centrum Veldhoven/Catharina hospital, Eindhoven, The Netherlands and Modena hospital, Modena, Italy. Data will be collected from patient records in an uniform database. Data will include demographic data, CLL stadium (RAI and Binet) at diagnosis and at the time of irradiation treatment, clinical data at diagnosis (haematology), splenic irradiation data, follow-up data such as date of progression or death

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-12-12
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-24
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• patients with chronic lymphatic leukaemia.

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Chronic Lymphatic Leukemia	splenic irradiation	Patients with Chronic Lymphatic Leukemia treated with splenic irradiation

Primary Outcome Measures

Name	Time	Method
Clinical and haematological response	13 years	Clinical and haematological response measured by number of leucocytes and thrombocytes during and after irradiation. Hemoglobin and size of spleen during and after irradiation in the time period 2000 tot 2013

Secondary Outcome Measures

Name	Time	Method
Progression of chronic Lymphatic leukaemia	13 years	Progression of chronic Lymphatic leukaemia after irradiation in the time period 2000 tot 2013
Death	13 years	Patients will be followed from the time of splenic irradiation to death in the time period of 2000 tot 2013
Toxicity of splenic irradiation	13 years	Toxicity of splenic irradiation during and after irradiation measured by evaluating clinical toxicity based on the CTCAE version 3.0 during and after irradiation (2000 to 2013)

Trial Locations

Locations (1)

Maastro Clinic; 🇳🇱 Maastricht, Netherlands