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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)

Must not have

Serious medical co-morbidities precluding radiotherapy

Clinical evidence of spinal cord compression

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious health issues that prevent me from receiving radiation therapy.

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I have signs of pressure on my spinal cord.

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My spinal cord has been exposed to over 30 Gy of radiation.

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I have a single plasma cell tumor.

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More than two of my organs need special care during treatment.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Control of RINV Radiation Induced Nausea and Vomiting (RINV)

Economic Analysis

Patient Reported Fatigue, Nausea, Vomiting

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 10Eligibility criteria met