Hair-sparing Whole Brain Radiotherapy

NCT ID: NCT01421316

Last Updated: 2015-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-10-31

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.

Conditions

Brain Metastases; Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Whole brain radiotherapy with volumetric arc therapy

Whole brain radiotherapy with volumetric arc therapy is used.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ghent University Hospital, Belgium

Ghent, , Belgium

Countries

Belgium

Other Identifiers

2011/504

Identifier Type: -

Identifier Source: org_study_id