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Radiation Therapy

SUPR vs 3D Radiotherapy for Bone Metastases from Cancer

N/A

Recruiting

Led By Rob Olson, MD

Research Sponsored by British Columbia Cancer Agency

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be prescribed a 5-HT3 receptor antagonist (e.g. Ondansetron) as antiemetic prophylaxis prior to RT start

Clinical diagnosis of cancer with bone metastases (biopsy not required)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 weeks, and 4 weeks post treatment

Awards & highlights

Study Summary

This trial is testing whether a different type of radiation therapy can help control nausea and vomiting caused by radiation therapy, with the goal of improving quality of life.

Who is the study for?

This trial is for adults with cancer who have bone metastases and are receiving palliative radiotherapy. They must be taking a specific anti-nausea medication, have no more than three radiation fields needing treatment, and not be pregnant or breastfeeding. Patients should be able to complete quality of life questionnaires and follow-up visits.Check my eligibility

What is being tested?

The SUPR-3D study compares the effects on quality of life between standard palliative radiotherapy (SUPR) and Volumetric Modulated Arc Therapy (VMAT). It focuses on controlling nausea/vomiting from radiation and will also evaluate pain response, although no difference is expected in pain control.See study design

What are the potential side effects?

Potential side effects may include Radiation Induced Nausea and Vomiting (RINV), which the trial aims to manage. Other common side effects from radiotherapy can range from skin reactions at the treatment site to fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am prescribed medication to prevent vomiting before starting radiation therapy.

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My cancer has spread to my bones.

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I am receiving targeted radiation for bone metastases in my mid to lower spine or pelvis.

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I can care for myself but may not be able to do heavy physical work.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 weeks, and 4 weeks post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 weeks, and 4 weeks post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, and 4 weeks post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient Reported Quality of life related to Radiation Induced Nausea and Vomiting (RINV)

Secondary outcome measures

Control of RINV Radiation Induced Nausea and Vomiting (RINV)

Economic Analysis

Patient Reported Fatigue, Nausea, Vomiting

+3 more

Trial Design

2Treatment groups

Active Control

Group I: VMAT rapid (Arm 2)Active Control1 Intervention

Contouring: GTV based on available imaging (CT sim scan alone-no special imaging), expect to be between 1.5cm and 20cm clinically or from imaging. CTV-optional in all scenarios. If using CTV=GTV +0.5 to 0.7cm adjust to anatomy as follows: If only bone involved: recommend not to expand past bone; but a 0.5-0.7cm CTV expansion outside of bone into muscle or soft tissue is allowed at RO discretion If bone and soft tissue involved: 0.5 to 0.7cm CTV expansion is optional, allowed at RO discretion If spinal metastases: CTV is optional. If used can include whole vertebral body at RO discretion PTV=CTV or GTV+(1 to 1.5)cm at RO discretion. PTV_eval=PTV cropped 0.5cm below skin. OARs: max 2 OARs permitted for VMAT arm. OAR constraints are at RO discretion. If lung/kidneys are within 5cm of PTV, absence of constraints for contours should be noted in treatment plans or dose constraint sheet prior to planning. PTV can be compromised for OAR at RO's discretion. Kidneys considered 1 organ

Group II: SUPR (Arm 1)Active Control1 Intervention

Planning according to local protocols. No more than 2 fields; no beam modifying devices, other than multileaf collimators (MLCs). Alternate weighting of beams allowed (ie. 1:2 AP:PA). Review of dosimetry not required, if performed as per institutional standard. Minimum of kV image matching on unit daily.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

British Columbia Cancer AgencyLead Sponsor

171 Previous Clinical Trials

90,261 Total Patients Enrolled

Rob Olson, MDPrincipal InvestigatorBritish Columbia Cancer Agency

Media Library

SUPR (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03694015 — N/A

Cancer Research Study Groups: VMAT rapid (Arm 2), SUPR (Arm 1)

Cancer Clinical Trial 2023: SUPR Highlights & Side Effects. Trial Name: NCT03694015 — N/A

SUPR (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03694015 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent has this research project been implemented geographically?

"Currently, seven medical centres are running this trial. These locations include Surrey, Prince George and Toronto in addition to other sites across the country. To reduce any travel burden on participants, it is advised that they elect a clinic located closest to their residence."

Answered by AI

Is there availability for eligible patients to join this clinical trial?

"Clinicaltrials.gov confirms that this research program is open for entry. First posted on December 2nd 2019, its most recent update was recorded on April 6th 2022."

Answered by AI

How many participants are being recruited for this experiment?

"Yes, the details on clinicaltrials.gov verify that this research project is actively looking for people to take part in it. It was originally posted on December 2nd 2019 and most recently updated April 6th 2022; 250 participants are needed from 7 distinct sites."

Answered by AI