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

Trial Summary

What is the purpose of this trial?

The primary objective is to patient-reported Quality of Life related to complete control of Radiation Induced Nausea and Vomiting (RINV) between standard palliative radiotherapy and VMAT. Secondarily, we will assess rate of complete control of RINV. However, the investigators hypothesize that there will be no difference in pain response between the two arms, because they are receiving the same dose.

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 data supports the effectiveness of the treatment SUPR, Simple Unplanned Palliative Radiotherapy, 3D Conformal Radiotherapy, and VMAT for bone metastases from cancer?

Research suggests that Volumetric Modulated Arc Therapy (VMAT) can improve the quality of life for patients by reducing the impact on normal tissues compared to 3D Conformal Radiotherapy (3DCRT). VMAT is also shown to be efficient in planning and delivering treatment for bone metastases, which can be beneficial in a palliative care setting. ^{1 2 3 4 5}

Is VMAT generally safe for use in humans?

VMAT (Volumetric Modulated Arc Therapy) is a type of radiation therapy that has been used safely in various conditions, including lung and brain cancers. It is designed to minimize exposure to healthy tissues while effectively targeting cancerous areas, which suggests a favorable safety profile. ^{2 3 6 7 8}

How does the SUPR vs 3D Radiotherapy treatment for bone metastases differ from other treatments?

The SUPR treatment, using Volumetric Modulated Arc Therapy (VMAT), is unique because it delivers radiation in a highly conformal manner, reducing treatment times and minimizing radiation exposure to healthy tissues compared to traditional 3D Conformal Radiotherapy. This approach aims to improve patient quality of life by decreasing treatment-related side effects and shortening the duration of each session. ^{1 2 7 8 9}

Research Team

Rob Olson, MD

Principal Investigator

British Columbia Cancer Agency

Eligibility Criteria

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.

I may benefit from a specific radiation dose.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 '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) 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]

References

1. United States 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? [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Quality of Life: A Prospective Randomized Trial of Palliative Volumetric Arc Therapy Versus 3-Dimensional Conventional Radiation Therapy. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Volumetric modulated arc therapy for delivery of hypofractionated stereotactic lung radiotherapy: A dosimetric and treatment efficiency analysis. [2022]

4. England 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. [2021]

5. India 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Volumetric modulated arc therapy planning for distal oesophageal malignancies. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of Rapid to Standard Volumetric Modulated Arc Therapy for Palliative Radiotherapy in Lung Cancer Patients. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

The feasibility and benefits of using volumetric arc therapy in patients with brain metastases: a systematic review. [2021]

9. United States 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. [2020]