Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Robert Olson, British Columbia Cancer Agency

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.

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes Radiation: SUPR Radiation: VMAT Not Applicable

Show Show detailed description

Layout table for study information
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

Resource links provided by the National Library of Medicine


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:

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Control of RINV Radiation Induced Nausea and Vomiting (RINV) [ Time Frame: day 1-5 ]
    as measured by a daily patient diary (day 1-5)

  2. Patient Reported Pain Response [ Time Frame: baseline, 2 weeks, and 4 weeks post treatment ]
    as measured by the Brief Pain Inventory

  3. Patient Reported Use of Medications [ Time Frame: baseline, 2 weeks, and 4 weeks post treatment ]
    as measured by the Patient Diary

  4. Patient Reported Fatigue, Nausea, Vomiting [ Time Frame: baseline, 2 weeks, and 4 weeks post treatment ]
    as measured by the PRO-CTCAE

  5. Patient Reported Quality of Life [ Time Frame: baseline, 2 weeks, and 4 weeks post treatment ]
    as measured by EORTC QLQ C-15 PAL

  6. Economic Analysis [ Time Frame: baseline, 2 weeks, and 4 weeks post treatment ]
    as measured by EQ-5D-5L



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Hadassah Abraham 250-645-7300 hadassah.abraham@bccancer.bc.ca

Locations
Layout table for location information
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      
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Layout table for investigator information
Principal Investigator: Rob Olson, MD British Columbia Cancer Agency
  Study Documents (Full-Text)

Documents provided by Robert Olson, British Columbia Cancer Agency:
Informed Consent Form  [PDF] April 9, 2021

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes