SUPR-3D: Simple Unplanned Palliative Radiotherapy Versus 3D Conformal Radiotherapy for Patients With Bone Metastases
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03694015 |
Recruitment Status :
Recruiting
First Posted : October 3, 2018
Last Update Posted : April 7, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes | Radiation: SUPR Radiation: VMAT | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 250 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Simple randomization with stratification will be used to randomly assign patients to either Arm 1 or Arm 2 in a 1:1 ratio using a computer-generated randomization scheme. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | SUPR-3D: A Randomized Phase III Trial Comparing Simple Unplanned Palliative Radiotherapy Versus 3D Conformal Radiotherapy for Patients With Bone Metastases |
Actual Study Start Date : | December 2, 2019 |
Estimated Primary Completion Date : | June 2023 |
Estimated Study Completion Date : | June 2028 |

Arm | Intervention/treatment |
---|---|
Active Comparator: SUPR (Arm 1)
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. |
Radiation: SUPR
simple unplanned palliative radiotherapy-(either 8 Gy in 1 fraction or 20 Gy in 5 fractions), chosen pre-randomization at ROs or centres discretion |
Active Comparator: VMAT rapid (Arm 2)
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:
|
Radiation: VMAT
volumetric modulated arc therapy--(either 8 Gy in 1 fraction or 20 Gy in 5 fractions), chosen pre-randomization at ROs or centres discretion |
- Patient Reported Quality of life related to Radiation Induced Nausea and Vomiting (RINV) [ Time Frame: day 1-5 ]RINV as measured by the Functional Living Index - Emesis (FLIE) at day 5 post RT start
- Control of RINV Radiation Induced Nausea and Vomiting (RINV) [ Time Frame: day 1-5 ]as measured by a daily patient diary (day 1-5)
- Patient Reported Pain Response [ Time Frame: baseline, 2 weeks, and 4 weeks post treatment ]as measured by the Brief Pain Inventory
- Patient Reported Use of Medications [ Time Frame: baseline, 2 weeks, and 4 weeks post treatment ]as measured by the Patient Diary
- Patient Reported Fatigue, Nausea, Vomiting [ Time Frame: baseline, 2 weeks, and 4 weeks post treatment ]as measured by the PRO-CTCAE
- Patient Reported Quality of Life [ Time Frame: baseline, 2 weeks, and 4 weeks post treatment ]as measured by EORTC QLQ C-15 PAL
- Economic Analysis [ Time Frame: baseline, 2 weeks, and 4 weeks post treatment ]as measured by EQ-5D-5L

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 or older
- Able to provide informed consent
- Clinical diagnosis of cancer with bone metastases (biopsy not required)
- Currently being managed with palliative intent RT to 1-3 RT fields for bone metastases, at least one RT field (PTV) must (at least) partly lie within T11-L5 or pelvis.
- ECOG Performance Status 0-3
- Patient has been determined to potentially benefit from 8 Gy or 20 Gy
- Radiation Oncologist is comfortable prescribing 8 Gy in 1 fraction or 20 Gy in 5 fractions RT for bone metastases
- Negative pregnancy test result for women of child-bearing potential
- The baseline assessment must be completed within required timelines, prior to randomization.
- Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
- For simplicity of planning, expected GTV should be less than 20 cm based on radiological or clinical evidence
- Patient must be prescribed a 5-HT3 receptor antagonist (e.g. Ondansetron) as antiemetic prophylaxis prior to RT start.
Exclusion Criteria:
- Serious medical co-morbidities precluding radiotherapy
- Clinical evidence of spinal cord compression
- Spinal cord in treatment field has already received at least >30 Gy EQD2
- Whole brain radiotherapy within 4 weeks of RT start
- Solitary plasmacytoma
- Pregnant or lactating women
- Target volume cannot be encompassed by a single VMAT isocentre
- Custom mould room requirements (shells and other immobilization that is standard-of-care is acceptable)
- Greater than two organs-at-risk requiring optimization.
- Patients requiring treatments outside standard clinical hours
- Implanted electronic device within 10 cm of the RT fields
- Prostheses in the axial plane of the target, or within 1 cm of the PTV out-of-plane
- Previous RT that requires an analysis of cumulative dose (i.e. sum plans or EQD2 calculations)
- Oral or IV contrast if the local standard-of-care requires compensation for this in planning.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694015
Contact: Hadassah Abraham | 250-645-7300 | hadassah.abraham@bccancer.bc.ca |
Canada, British Columbia | |
BC Cancer | Recruiting |
Prince George, British Columbia, Canada, V2M 7E9 | |
Contact: Robert A Olson, MD 2506457300 rolson2@bccancer.bc.ca | |
Contact: Hadassah Abraham 2506457300 hadassah.abraham@bccancer.bc.ca | |
Principal Investigator: Robert A Olson | |
BC Cancer | Recruiting |
Vancouver, British Columbia, Canada | |
Contact: Shilo Lefresne, MD 2506457300 SLefresne@bccancer.bc.ca | |
BC Cancer - Victoria | Recruiting |
Victoria, British Columbia, Canada | |
Contact: Tanya Berrang, MD 250-519-5577 TBerrang@bccancer.bc.ca | |
Canada, Ontario | |
London Health Sciences Centre | Recruiting |
London, Ontario, Canada | |
Contact: Joanna Laba, MD (519) 685-8500 Joanna.Laba@lhsc.on.ca | |
Princess Margaret Cancer Centre | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Aisling Barry, MD (416) 946-2000 |
Principal Investigator: | Rob Olson, MD | British Columbia Cancer Agency |
Documents provided by Robert Olson, British Columbia Cancer Agency:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Robert Olson, Radiation Oncologist & Department Head Radiation Oncology & Developmental Radiotherapeutics, British Columbia Cancer Agency |
ClinicalTrials.gov Identifier: | NCT03694015 |
Other Study ID Numbers: |
SUPR-3D |
First Posted: | October 3, 2018 Key Record Dates |
Last Update Posted: | April 7, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Neoplasms Neoplasm Metastasis Neoplastic Processes Pathologic Processes |