To prove the clinical feasibility of palliative whole brain radiotherapy without using a thermoplastic mask. Clinical feasibility in this study is defined when more than 70% of the patients can complete the radiation treatment without a mask. We…
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rate of success of the treatment.
Secondary outcome
- Intra-fractional movement: the total amount of movements of the head during a
fraction, detected by a surface scanner .
- Intra-fractional position: difference between the position at the start and
the end of a fraction
- MV-cine imaging: movement of the head during a fraction.
Background summary
During radiation of the brain, a thermoplastic mask is used to fixate the head,
preventing movements during the treatment. However, many patients complain
about the tightness and experience discomfort. Therefore, a treatment method
without the necessity of a head mask is of advantage for patients. An optical
surface scanner can be used as a movement monitoring tool during radiation
therapy of the head. We will evaluate whether stabilization of the back of the
head is sufficient, such that movement is minimized, which is needed for whole
brain radiotherapy.
Based on literature we expect patients to be able to lie still during the
treatment. With sufficient support of the head and by using an optical surface
scanner, we expect a mask is not necessary.
Study objective
To prove the clinical feasibility of palliative whole brain radiotherapy
without using a thermoplastic mask. Clinical feasibility in this study is
defined when more than 70% of the patients can complete the radiation treatment
without a mask. We suppose a failure of less than 30% to be acceptable for both
patients and clinicians. A complete treatment consists of five fractions. The
treatment is considered to be successful when three or more fractions of one
patient have been successful. A fraction is defined to be successful if no more
than two times a session, repositioning is needed.
Study design
The study is a clinical feasibility study. All subjects participating in the
study receive whole brain radiotherapy without using a thermoplastic mask.
Intervention
The intervention in this study concerns the treatment method of whole brain
radiotherapy; the treatment itself is the same whether patients participate in
the study or not. Patients are instructed to lie as still as possible on the
treatment table and not to move their head during the radiotherapy treatment.
As is common with radiotherapy of the head, online imaging is used for a
reproducible inter-fractional position of the head. For movement detection
during the treatment an optical surface scanner is used. The surface scanner
used for this study is the Catalyst* (C-RAD AB, Sweden), which constructs a
3D-reconstruction of a subject. The actual position of the patient is compared
to a daily made reference image and the deviation is presented on a screen. If
it becomes clear a patient is not able to lie still, the treatment can be
continued by using a mask.
Study burden and risks
If the movement of the head exceeds the threshold, the radiation is temporary
stopped. The technologist repositions the patient and the radiation continues.
The treatment can in any case be continued using a mask during the next
fraction. Therefore, an unsuccessful treatment method has no consequences for
the effectiveness of the radiotherapy for the patient.
Brugstraat 10
Tilburg 5042SB
NL
Brugstraat 10
Tilburg 5042SB
NL
Listed location countries
Age
Inclusion criteria
- The therapy is aimed to be palliative and consists of whole brain radiation therapy, 5x4 Gy.
- The patient is motivated and willing to be involved in radiotherapy without a mask.
- According to the impression of the radiation oncologist, the patient is able to lie still during the treatment.
- The patient is competent enough to understand the Dutch language to follow up instructions of the radiation technologist.
Exclusion criteria
Suffering from trembling or shaking of the head, for example caused by Parkinson*s disease.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL61854.028.17 |