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Hair-sparing Whole Brain Radiotherapy

Primary Purpose

Brain Metastases, Small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Whole brain radiotherapy with volumetric arc therapy
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases focused on measuring Patients treated with whole brain radiotherapy in the setting of brain metastases, Patients treated with whole brain radiotherapy in the prophylactic treatment for small cell lung cancer (extended disease).

Eligibility Criteria

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

Inclusion Criteria:

  • Brain metastases
  • Age ≥ 18 years.
  • Signed informed consent
  • Recursive Partitioning Analysis (RPA) class III patients
  • Recursive Partitioning Analysis (RPA) class I-II patients and >3 brain metastases
  • Patients with small cell lung cancer extended disease eligible for prophylactic Whole-Brain Radiotherapy (WBRT).

Exclusion Criteria:

  • Previous whole brain radiotherapy

Sites / Locations

  • Ghent University Hospital, Belgium

Outcomes

Primary Outcome Measures

The European Organization for Research and Treatment of Cancer (EORTC)quality of life questionnaire (C15-PAL and BN20) measured at 1 month following treatment.
Quality of life questionnaires are used.

Secondary Outcome Measures

Hair quality before treatment and at 1 month following treatment.
Key measurements: trichogram are used.

Full Information

First Posted
August 17, 2011
Last Updated
June 3, 2015
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01421316
Brief Title
Hair-sparing Whole Brain Radiotherapy
Official Title
Reducing Hair Loss With Volumetric Arc Therapy in Patients Treated With Whole Brain Radiotherapy: a Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
No reduction in hair loss 1 month after treatment
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Up to 10% of patients with cancer will develop symptomatic brain metastases. Given this limited survival it is important to consider quality of life (QOL) when treating these patients. Whole brain radiotherapy (WBRT) can increase survival to 6 month. However, WBRT itself has been shown to reduce QOL by increasing drowsiness, leg weakness and hair loss in patients with brain metastases. Both fatigue and hair loss were reported to have the largest decline in QOL scores when WBRT is used in the prophylactic setting in small cell lung cancer. Recent technological improvements in patient positioning and treatment planning will allow us to treat the whole brain with reduced margins, allowing better sparing of the scalp. In view of the large impact of hair loss on quality of life, the investigators hypothesize to see an improved quality of life with scalp sparing techniques. Study hypothesis: Volumetric arc therapy results in a reduced hair loss and a subsequent clinically important improvement in QOL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases, Small Cell Lung Cancer
Keywords
Patients treated with whole brain radiotherapy in the setting of brain metastases, Patients treated with whole brain radiotherapy in the prophylactic treatment for small cell lung cancer (extended disease).

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
Whole brain radiotherapy with volumetric arc therapy
Intervention Description
Whole brain radiotherapy with volumetric arc therapy is used.
Primary Outcome Measure Information:
Title
The European Organization for Research and Treatment of Cancer (EORTC)quality of life questionnaire (C15-PAL and BN20) measured at 1 month following treatment.
Description
Quality of life questionnaires are used.
Time Frame
At 1 month.
Secondary Outcome Measure Information:
Title
Hair quality before treatment and at 1 month following treatment.
Description
Key measurements: trichogram are used.
Time Frame
at 1 month following treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Brain metastases Age ≥ 18 years. Signed informed consent Recursive Partitioning Analysis (RPA) class III patients Recursive Partitioning Analysis (RPA) class I-II patients and >3 brain metastases Patients with small cell lung cancer extended disease eligible for prophylactic Whole-Brain Radiotherapy (WBRT). Exclusion Criteria: Previous whole brain radiotherapy
Facility Information:
Facility Name
Ghent University Hospital, Belgium
City
Ghent
Country
Belgium

12. IPD Sharing Statement

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Hair-sparing Whole Brain Radiotherapy

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