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Evaluation of Fast, Same-day Delivery of Palliative Radiotherapy Without a Planning CT (FAST-METS)

Patient- Reported Outcomes After Fast Same-day Delivery of Palliative Radiotherapy Without Planning CT Using an Adaptive Delivery Platform (FAST-METS)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05288608
Acronym
FAST-METS
Enrollment
60
Registered
2022-03-21
Start date
2021-12-16
Completion date
2023-03-16
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastasis

Brief summary

Palliative radiotherapy is an effective treatment for patients with painful bone metastases. Standard workflows often involve long waiting times or multiple visits. Fast palliation completed during a single clinic visit can be achieved by omitting a planning CT scan, and using available diagnostic imaging for treatment planning. The adaptive treatment platforms provides the possibility to adapt positions differences between the diagnostic CT and radiotherapy treatment of the target and organs at risk. In this study, the investigators will investigate the experiences of patients who have been treated with this fast-adaptive workflow (FAST-METS) using 2 questionnaires.

Detailed description

Palliative radiotherapy is an effective treatment for patients with painful bone metastases, and currently the investigators have clinically implemented the FAST-METS procedure at the department. All patients referred for palliative radiotherapy, in whom diagnostic imaging performed within 4 weeks is available, are eligible for this adaptive workflow. Consultation by telephone is done beforehand to verify whether the complaints correspond to the location of the metastasis. This single-institutional, explorative study will investigate the experiences and quality of life of patients who were treated with this workflow. Two study questionnaires are used, and informed consent will be obtained for both. The EQ-5D-5L questionnaire will be completed on the day of treatment, after 6 weeks and 3 months post-treatment. The other questionnaire used was developed for patients treated with adaptive radiotherapy. Two patients groups will be studied, namely those undergoing simple and complex palliative radiotherapy. Patients treated with complex palliative radiotherapy are defined as those referred for re-irradiation to the site of metastasis, patients undergoing concurrent systemic therapy, and patients treated with a single fraction radiation dose exceeding 8 Gy. In addition, the study will evaluate time spent on treatment preparation and delivery proces, and dosimetric aspects of the treatment.

Interventions

None listed

Sponsors

Amsterdam UMC, location VUmc
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients referred for palliative radiotherapy to metastases * Recent diagnostic CT scan (preferably \<4 weeks) of the metastasis with full body contour of the patient included.

Exclusion criteria

* A solitairy metastasis from a primairy tumor with good a prognosis * A metastasis located in ventral ribs where respiratory motion of the target is expected * Patients who are not fluent in Dutch

Design outcomes

Primary

MeasureTime frameDescription
Quality of life of patients3 monthsQuality of life, with EQ-5D-5L questionnaires. The questionnaires comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Satisfaction of patients1 weekMeasure the satisfaction of patients who are treated with FAST-METS workflow, using a patient questionnaire developed in-house, which is completed on the day of treatment. Each question has 5 levels: not satisfied at all, some satisfaction, reasonably satisfied, and very satisfied

Secondary

MeasureTime frameDescription
Dosimetric data1 weekDosimetric data on treatment planning, containing volumes of gross tumor volume (GTV), planning target volume (PTV), coverage of GTV and PTV, dose to the organs at risk (OARs), technique of radiotherapy (IMRT/VMAT) and number of monitor units (MU). The data of the reference plan and the adapted plan will be collected and compared
Time spent on treatment preparation and delivery proces1 weekThe time spent in minutes at each step of the patient's treatment journey will be recorded, commencing from the start of clinical consultation until the patient leaves the radiotherapy department.

Countries

Netherlands

Contacts

Primary ContactEva Versteijne, MD, PhD
e.versteijne@amsterdamumc.nl+31621631021

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026