SUPR vs 3D Radiotherapy for Bone Metastases from Cancer

Recruiting at 5 trial locations

Overseen By Hadassah Abraham

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: British Columbia Cancer Agency

Must be taking: 5-HT3 antagonists

Disqualifiers: Spinal cord compression, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1-2 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of radiotherapy: SUPR (Simple Unplanned Palliative Radiotherapy) and VMAT (Volumetric Modulated Arc Therapy). The main goal is to assess how these treatments impact the quality of life for patients with bone metastases, particularly in managing nausea and vomiting caused by radiation. Participants must have cancer that has spread to their bones and be receiving palliative radiotherapy targeting specific areas in the lower spine or pelvis. As an unphased trial, this study provides an opportunity to contribute to research that could enhance symptom management for future patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must be prescribed a 5-HT3 receptor antagonist (a type of medication to prevent nausea) before starting the trial.

What prior data suggests that these radiotherapy techniques are safe for treating bone metastases?

Research has shown that both SUPR and VMAT treatments for bone cancer spread are generally manageable for patients. Radiotherapy, such as SUPR, relieves pain with few side effects. Studies indicate it can significantly reduce pain for many patients without causing serious issues.

For VMAT, research found that it targets cancer effectively while protecting healthy tissues, resulting in fewer side effects compared to some older methods. Patients often report feeling more comfortable and experiencing shorter treatment sessions.

Overall, both treatments have been used in many patients and are considered safe with minimal negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for bone metastases because they offer innovative approaches to radiotherapy. SUPR is distinctive because it simplifies treatment planning and administration by using fewer fields and avoiding complicated beam modifiers, potentially making the process quicker and more accessible. On the other hand, VMAT provides a highly targeted radiation delivery that can be adjusted based on the precise location and extent of the metastases, which may improve precision and reduce damage to surrounding healthy tissues. Both treatments aim to improve the effectiveness and safety of radiotherapy for patients with bone metastases, offering potential advantages over traditional methods.

What evidence suggests that this trial's treatments could be effective for controlling Radiation Induced Nausea and Vomiting?

This trial will compare SUPR and VMAT as treatments for bone metastases from cancer. Research has shown that palliative radiotherapy, like SUPR, effectively reduces pain in patients with cancer that has spread to the bones. Many patients experience less pain after this treatment. Studies have found that SUPR is simple to use and doesn't require complicated planning, making it easier to administer.

In contrast, VMAT (Volumetric Modulated Arc Therapy), which participants in this trial may receive, shows promise by protecting nearby healthy organs while treating cancer-affected bones. It allows better control over the radiation dose, potentially leading to fewer side effects and more comfort. Both treatments aim to manage symptoms, but VMAT might offer additional benefits by reducing harm to healthy tissues. ^{1 2 3 4 5}

Who Is on the Research Team?

Rob Olson, MD

Principal Investigator

British Columbia Cancer Agency

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am willing and able to complete study questionnaires online or on paper.

Able to provide informed consent

Exclusion Criteria

Pregnant or lactating women

Implanted electronic device within 10 cm of the RT fields

I have had radiation therapy that needs dose evaluation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy Planning

Planning for radiotherapy treatment, including CT simulation and treatment plan development

3 days

1 visit (in-person)

Treatment

Participants receive either SUPR or VMAT radiotherapy for bone metastases

1-2 weeks

Daily visits for treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SUPR
• VMAT

Trial Overview 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.

How Is the Trial Designed?

Group I: VMAT rapid (Arm 2) Active Control 1 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 Control 1 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.

SUPR is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Palliative Radiotherapy for:

• Bone metastases
• Spinal cord compression
• Brain metastases

Approved in United States as Palliative Radiotherapy for:

• Bone metastases
• Spinal cord compression
• Brain metastases

Approved in Canada as Palliative Radiotherapy for:

• Bone metastases
• Spinal cord compression
• Brain metastases

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

Published Research Related to This Trial

In a phase 2 trial involving 69 patients with metastatic disease, palliative volumetric arc therapy (VMAT) showed less deterioration in quality of life (QOL) compared to 3-dimensional conformal radiation therapy (3DCRT) at 4 weeks post-treatment, despite both techniques being equally effective in pain control.

Patients receiving VMAT reported better physical, role, and social functioning, although they experienced more diarrhea symptoms compared to those treated with 3DCRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Life: A Prospective Randomized Trial of Palliative Volumetric Arc Therapy Versus 3-Dimensional Conventional Radiation Therapy. Wong, P., Lambert, L., Thanomsack, P., et al.[2021]

Volumetric modulated arc therapy (VMAT) significantly reduces lung dose volume parameters compared to traditional 3D-conformal radiation therapy (3D-CRT), indicating improved safety for surrounding healthy tissues during lung cancer treatment.

VMAT not only achieves highly conformal dose distributions but also reduces treatment times by 37-63%, enhancing efficiency and potentially minimizing errors during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volumetric modulated arc therapy for delivery of hypofractionated stereotactic lung radiotherapy: A dosimetric and treatment efficiency analysis. McGrath, SD., Matuszak, MM., Yan, D., et al.[2022]

A new 'rapid VMAT' planning technique allows for palliative radiotherapy to be delivered to lung cancer patients within 48 hours, maintaining similar dosimetric quality to standard VMAT plans.

In a study of 14 patients, both rapid and standard VMAT plans provided comparable coverage of the target tumor and similar doses to critical organs, ensuring effective treatment without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Rapid to Standard Volumetric Modulated Arc Therapy for Palliative Radiotherapy in Lung Cancer Patients. Mak, DY., Fraser, I., Ferris, R., et al.[2020]

Volumetric modulated arc therapy (VMAT) is a highly conformal radiotherapy technique that significantly reduces treatment delivery times and shows no significant toxicities compared to whole-brain radiation therapy (WBRT), stereotactic radiosurgery (SRS), and intensity modulated radiotherapy (IMRT).

VMAT provides similar dose distributions to IMRT while being less toxic than WBRT and faster than SRS, indicating its potential as an effective treatment option for patients with brain metastases, although further studies are needed to evaluate its long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility and benefits of using volumetric arc therapy in patients with brain metastases: a systematic review. Andrevska, A., Knight, KA., Sale, CA.[2021]

Volumetric modulated arc therapy (VMAT) for palliative radiation therapy to the lumbosacral spine was found to be dosimetrically superior, providing better dose conformity and homogeneity compared to traditional planning methods, with a conformity index of 1.2 for VMAT versus 2.0 for standard techniques.

Using VMAT reduced treatment delivery time to 1.5 minutes, similar to the fastest method (anterior-posterior parallel opposed pair), while also minimizing the dose to normal tissues, which can enhance the quality of life for patients undergoing palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Conformity-Based Volumetric Modulated Arc Therapy Improve Dosimetry and Speed of Delivery in Radiation Therapy to Lumbosacral Spine Compared with Conventional Techniques? Javor, J., Robbins, M., Rosewall, T., et al.[2021]

Volumetric modulated arc radiotherapy (VMAT) significantly improved target volume coverage in patients with locally advanced nonsmall cell lung cancer, achieving a median PTV coverage of 98.25% compared to 91.41% with traditional 3D-CRT (P < 0.001).

VMAT provided better dosimetric parameters, such as improved conformity index and dose homogeneity, without increasing the low-dose exposure to the lungs, although it required more monitor units and resulted in shorter treatment times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Actual gains in dosimetry and treatment delivery efficiency from volumetric modulated arc radiotherapy for inoperable, locally advanced lung cancer over five-field forward-planned intensity-modulated radiotherapy. Shrimali, RK., Arunsingh, M., Reddy, GD., et al.[2022]

Volumetric modulated arc therapy (VMATi) significantly reduces radiation exposure to the heart compared to conventional conformal plans, with heart doses at 30 Gy reduced from 55% to 31% in a study of 10 patients with oesophageal cancer.

VMATi not only provides better protection for surrounding organs but also shortens treatment time, delivering radiation in about 1 minute and 28 seconds compared to 3 minutes and 15 seconds for traditional methods, making it a more efficient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volumetric modulated arc therapy planning for distal oesophageal malignancies. Hawkins, MA., Bedford, JL., Warrington, AP., et al.[2021]

A new process for volumetric modulated arc therapy (VMAT) allows for same-day contouring, planning, quality assurance, and treatment delivery for vertebral bone metastases, completing all steps in under 2 hours.

The efficient planning variables identified include a 3 mm voxel size and Monte Carlo dose calculation, which optimize treatment while minimizing radiation exposure to surrounding organs like the lungs and kidneys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pre-implementation Study of Volumetric Modulated Arc Therapy for Same-day Planning and Treatment of Vertebral Bone Metastases Within a Rapid-access Palliative Radiotherapy Programme. Dennis, K., Linden, K., Zohr, R., et al.[2021]

Volumetric-modulated arc therapy (VMAT) significantly improves target coverage and reduces planning time for radiation therapy in patients with vertebral metastases, as shown in a retrospective analysis of 10 cases.

VMAT also decreases treatment delivery time from nearly 10 minutes to about 3 minutes, enhancing patient comfort and minimizing radiation-induced toxicities during palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliation of Vertebral Metastases with Radiotherapy: Exploration of Volumetric-Modulated Arc Therapy From Development to Implementation in Routine Clinical Practice. Rozanec, N., Allibhai, Z., Bhatti, M., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6819327/

SUPR-3D: A randomized phase iii trial comparing simple ... Bone metastases in the lower spine and pelvis are effectively palliated with radiotherapy (RT), though this can come with side effects such ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31660894/

SUPR-3D: A randomized phase iii trial comparing simple ... This is a randomized, multi-centre phase III trial of SUPR versus VMAT. We will accrue 250 patients to assess the difference in patient-reported RINV.

3. thegreenjournal.com thegreenjournal.com/article/S0167-8140(22)04130-5/fulltext

ESTRO ACROP guidelines for external beam ... Introduction of effective systemic treatment in many cancers has prolonged patients' survival, including those with bone metastases. Bone ...

4. researchgate.net researchgate.net/publication/336860981_SUPR-3D_A_randomized_phase_iii_trial_comparing_simple_unplanned_palliative_radiotherapy_versus_3d_conformal_radiotherapy_for_patients_with_bone_metastases_Study_protocol

(PDF) SUPR-3D: A randomized phase iii trial comparing ... SUPR-3D: A randomized phase iii trial comparing simple unplanned palliative radiotherapy versus 3d conformal radiotherapy for patients with bone ...

5. springermedizin.de springermedizin.de/supr-3d-a-randomized-phase-iii-trial-comparing-simple-unplanned-/17319500

SUPR-3D: A randomized phase iii trial comparing simple ... Palliative radiotherapy (RT) is an effective treatment for bone metastases, resulting in significant pain reduction in the majority of patients [ 2 ]. It is ...