SUPR-3D: Simple Unplanned Palliative Radiotherapy Versus 3D Conformal Radiotherapy for Patients With Bone Metastases

NCT03694015 | Terminated DMC

• 1 other identifier: SUPR-3D
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Neoplastic Processes; Neoplasms; Pathologic Processes; Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

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

  RINV as measured by the Functional Living Index - Emesis (FLIE) at day 5 post RT start

  day 1-5

Secondary Outcomes (6)

• Control of RINV Radiation Induced Nausea and Vomiting (RINV)

  day 1-5

• Patient Reported Pain Response

  baseline, 2 weeks, and 4 weeks post treatment

• Patient Reported Use of Medications

  baseline, 2 weeks, and 4 weeks post treatment

• Patient Reported Fatigue, Nausea, Vomiting

  baseline, 2 weeks, and 4 weeks post treatment

• Patient Reported Quality of Life

  baseline, 2 weeks, and 4 weeks post treatment

Study Arms (2)

SUPR (Arm 1)

ACTIVE COMPARATOR

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

VMAT rapid (Arm 2)

ACTIVE COMPARATOR

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

Radiation: VMAT

Interventions

SUPR RADIATION

simple unplanned palliative radiotherapy-(either 8 Gy in 1 fraction or 20 Gy in 5 fractions), chosen pre-randomization at ROs or centres discretion

SUPR (Arm 1)

VMAT RADIATION

volumetric modulated arc therapy--(either 8 Gy in 1 fraction or 20 Gy in 5 fractions), chosen pre-randomization at ROs or centres discretion

VMAT rapid (Arm 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient is able and willing to complete the quality of life questionnaires, and other assessments that are a part of this study, via paper or using PatientPortals.ca or REDCap if they provide their email address on the informed consent

You may not qualify if:

• 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 (WBRT) within 4 weeks of RT start or planned WBRT in the first 4 weeks after last RT
• 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.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (5)

BC Cancer

Prince George, British Columbia, V2M 7E9, Canada

Location

BC Cancer

Vancouver, British Columbia, Canada

Location

BC Cancer - Victoria

Victoria, British Columbia, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (8)

• Teoh M, Clark CH, Wood K, Whitaker S, Nisbet A. Volumetric modulated arc therapy: a review of current literature and clinical use in practice. Br J Radiol. 2011 Nov;84(1007):967-96. doi: 10.1259/bjr/22373346.

  PMID: 22011829 BACKGROUND

• Webb S. Advances in treatment with intensity-modulated conformal radiotherapy. Tumori. 1998 Mar-Apr;84(2):112-26. doi: 10.1177/030089169808400206.

  PMID: 9620234 BACKGROUND

• Guerrero Urbano MT, Nutting CM. Clinical use of intensity-modulated radiotherapy: part I. Br J Radiol. 2004 Feb;77(914):88-96. doi: 10.1259/bjr/84246820.

  PMID: 15010378 BACKGROUND

• Miles EA, Clark CH, Urbano MT, Bidmead M, Dearnaley DP, Harrington KJ, A'Hern R, Nutting CM. The impact of introducing intensity modulated radiotherapy into routine clinical practice. Radiother Oncol. 2005 Dec;77(3):241-6. doi: 10.1016/j.radonc.2005.10.011. Epub 2005 Nov 17.

  PMID: 16298002 BACKGROUND

• Chow E, Zeng L, Salvo N, Dennis K, Tsao M, Lutz S. Update on the systematic review of palliative radiotherapy trials for bone metastases. Clin Oncol (R Coll Radiol). 2012 Mar;24(2):112-24. doi: 10.1016/j.clon.2011.11.004. Epub 2011 Nov 29.

  PMID: 22130630 BACKGROUND

• Lutz S, Berk L, Chang E, Chow E, Hahn C, Hoskin P, Howell D, Konski A, Kachnic L, Lo S, Sahgal A, Silverman L, von Gunten C, Mendel E, Vassil A, Bruner DW, Hartsell W; American Society for Radiation Oncology (ASTRO). Palliative radiotherapy for bone metastases: an ASTRO evidence-based guideline. Int J Radiat Oncol Biol Phys. 2011 Mar 15;79(4):965-76. doi: 10.1016/j.ijrobp.2010.11.026. Epub 2011 Jan 27.

  PMID: 21277118 BACKGROUND

• Nielsen OS. Palliative radiotherapy of bone metastases: there is now evidence for the use of single fractions. Radiother Oncol. 1999 Aug;52(2):95-6. doi: 10.1016/s0167-8140(99)00109-7. No abstract available.

  PMID: 10577693 BACKGROUND

• Olson R, Schlijper R, Chng N, Matthews Q, Arimare M, Mathews L, Hsu F, Berrang T, Louie A, Mou B, Valev B, Laba J, Palma D, Schellenberg D, Lefresne S. SUPR-3D: A randomized phase iii trial comparing simple unplanned palliative radiotherapy versus 3d conformal radiotherapy for patients with bone metastases: study protocol. BMC Cancer. 2019 Oct 28;19(1):1011. doi: 10.1186/s12885-019-6259-z.

  PMID: 31660894 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Rob Olson, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist & Department Head Radiation Oncology & Developmental Radiotherapeutics

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: December 2, 2019
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)