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

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.

Study Overview

• Status: Recruiting
• Conditions: Metastasis

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Eva Versteijne, MD, PhD; Phone Number: +31621631021; Email: e.versteijne@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • AmsterdamUMC, location VUmc
    • Contact: Eva Versteijne, MD, PhD; Email: e.versteijne@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients referred for palliative radiotherapy, in whom diagnostic imaging performed in the preceding 4 weeks is available.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	1 week

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Anticipated): December 16, 2022
• Study Completion (Anticipated): March 16, 2023

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 2021.0568

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No