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

NCT05288608 | Unknown

• 1 other identifier: 2021.0568
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastasis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Dosimetric data

  1 week

• Time spent on treatment preparation and delivery proces

  1 week

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

AmsterdamUMC, location VUmc

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. dr. Suresh Senan, MD, PhD

  Amsterdam UMC, location VUmc, Department Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Versteijne, MD, PhD

CONTACT

+31621631021; e.versteijne@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical professor

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 21, 2022
• Study Start: December 16, 2021
• Primary Completion: December 16, 2022
• Study Completion: March 16, 2023
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

NL (1)