Hair-sparing Whole Brain Radiotherapy

Small Cell Lung Cancer Clinical Trial

Official title:

Reducing Hair Loss With Volumetric Arc Therapy in Patients Treated With Whole Brain Radiotherapy: a Phase II Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01421316
• Other study ID #: 2011/504
• Status: Terminated
• Phase: Phase 2
• First received: August 17, 2011
• Last updated: June 3, 2015
• Start date: January 2013
• Est. completion date: October 2014

Study information

• Verified date: June 2015
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: October 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Metastases
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Radiation:
• Whole brain radiotherapy with volumetric arc therapy
Whole brain radiotherapy with volumetric arc therapy is used.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital, Belgium	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 1 month.	No
Secondary	Hair quality before treatment and at 1 month following treatment.	Key measurements: trichogram are used.	at 1 month following treatment	No