MetastasisFAST-METSNCT05288608
Evaluation of Fast, Same-day Delivery of Palliative Radiotherapy Without a Planning CT (FAST-METS)
An observational study of Metastasis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastasis
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Dec 2021to 16 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for palliative radiotherapy, in whom diagnostic imaging performed in the preceding 4 weeks is available.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
AmsterdamUMC, location VUmc
Amsterdam
Eva Versteijne, MD, PhD, e.versteijne@amsterdamumc.nl
About this study
Official title: Patient- Reported Outcomes After Fast Same-day Delivery of Palliative Radiotherapy Without Planning CT Using an Adaptive Delivery Platform (FAST-METS)
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.
Read the 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.
- Conditions
- Metastasis
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Simple palliation | Treatment of patients who are referred for palliative radiotherapy to uncomplicated metastases. | |
| Complex palliation | Treatment of patients who require treatment to a site of previous radiation, patients undergoing concurrent systemic therapy, and those requiring a radiation dose exceeding 8 Gy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life of patients
Quality 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.
Measured: 3 months
Satisfaction of patients
Measure 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
Measured: 1 week
Secondary outcomes (2)
Dosimetric data
Dosimetric 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
Measured: 1 week
Time spent on treatment preparation and delivery proces
The 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start16 Dec 2021
- Primary completion16 Dec 2022 (estimated)
- Study completion16 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetastasisStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suresh Senan, Amsterdam UMC, location VUmc
- Investigators
- Prof. dr. Suresh Senan, MD, PhD, Principal investigator, Amsterdam UMC, location VUmc, Department Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288608
- Sponsor's protocol ID
- 2021.0568
- Acronym
- FAST-METS
- Status last verified
- Mar 2022
- First submitted
- 28 Feb 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient- Reported Outcomes After Fast Same-day Delivery of Palliative Radiotherapy Without Planning CT Using an Adaptive Delivery Platform (FAST-METS)
- ClinicalTrials.gov ID
- NCT05288608
- Acronym / sponsor ID
- FAST-METS / 2021.0568
- Conditions
- Metastasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 16 Dec 2022 (estimated)
- Study completion
- 16 Mar 2023 (estimated)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple palliation | – | –Treatment of patients who are referred for palliative radiotherapy to uncomplicated metastases. |
| Complex palliation | – | –Treatment of patients who require treatment to a site of previous radiation, patients undergoing concurrent systemic therapy, and those requiring a radiation dose exceeding 8 Gy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for palliative radiotherapy, in whom diagnostic imaging performed in the preceding 4 weeks is available.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life of patients
Time frame: 3 months
Quality 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 patients
Time frame: 1 week
Measure 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
2 secondary outcomes
Dosimetric data
Time frame: 1 week
Time spent on treatment preparation and delivery proces
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. dr. Suresh Senan, MD, PhD principal investigator
Amsterdam UMC, location VUmc, Department Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastasis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Versteijne, MD, PhD (+31621631021, e.versteijne@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life of patients (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.