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

Sponsor
Amsterdam UMC, location VUmc (Other)
Overall Status
Recruiting
CT.gov ID
NCT05288608
Collaborator
(none)
60
1
14.9
4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Patient- Reported Outcomes After Fast Same-day Delivery of Palliative Radiotherapy Without Planning CT Using an Adaptive Delivery Platform (FAST-METS)
    Actual Study Start Date :
    Dec 16, 2021
    Anticipated Primary Completion Date :
    Dec 16, 2022
    Anticipated Study Completion Date :
    Mar 16, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Quality of life of patients [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.

    2. Satisfaction of patients [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

    Secondary Outcome Measures

    1. Dosimetric data [1 week]

      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

    2. Time spent on treatment preparation and delivery proces [1 week]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AmsterdamUMC, location VUmc Amsterdam Netherlands

    Sponsors and Collaborators

    • Amsterdam UMC, location VUmc

    Investigators

    • Principal Investigator: Prof. dr. Suresh Senan, MD, PhD, Amsterdam UMC, location VUmc, Department Radiation Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Suresh Senan, Principal Investigator, Clinical professor, Amsterdam UMC, location VUmc
    ClinicalTrials.gov Identifier:
    NCT05288608
    Other Study ID Numbers:
    • 2021.0568
    First Posted:
    Mar 21, 2022
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 4, 2022