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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 : February 21, 2020
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

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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 : January 2023
Estimated Study Completion Date : January 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; expected to be between 1.5 cm and 20 cm clinically or from diagnostic imaging CTV = GTV + 0.5 to 0.7 cm (RO preference), adjusted to anatomy.

  • if only bone involvement: no margin outside the bone
  • if bone and soft tissue involvement: no margin outside the bone, only adapt CTV margin in soft tissue to organs. No CTV adaptation in i.e. muscle.
  • CTV maybe optional and if used can encompasses whole vertebral body as per RO's discretion PTV = CTV or GTV + (1 to 1.5) cm as per RO/centre preference. PTV_eval = PTV cropped 0.5 cm below skin. OAR's: maximum 2 OARs permitted for VMAT arm. OAR contouring/constraints are at discretion of treating RO. However, if lung/kidneys are within 5 cm of PTV, absence of constraints for these contours should be documented in treatment plans or dose constraint sheet prior to planning. PTV can be compromised for OAR at radiation oncologist's discretion. Kidneys are 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

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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 bone metastases, at least one of which 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
  • Pregnancy test for women of child-bearing potential
  • Patient is able (i.e. sufficiently fluent) and willing to complete the patient-reported outcomes quality of life questionnaires in English. 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 5HT-3 receptor antagonist (e.g. Ondansetron) or dexamethose 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
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Contact: Rob Olson, MD 18557557300 rolson2@bccancer.bc.ca
Contact: Lindsay Mathews 18557557300 mathews@unbc.ca

Locations
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Canada, British Columbia
BC Cancer Not yet recruiting
Abbotsford, British Columbia, Canada
Contact: Fred Hsu, MD    604-851-4742    fhsu-02@bccancer.bc.ca   
BC Cancer Not yet recruiting
Kelowna, British Columbia, Canada
Contact: Benjamin Mou, MD       Benjamin.Mou@bccancer.bc.ca   
BC Cancer Recruiting
Prince George, British Columbia, Canada, V2M 7E9
Contact: Robert A Olson, MD    2506457300    rolson2@bccancer.bc.ca   
Contact: Lindsay Mathews    2506457300    lindsay.mathews@bccancer.bc.ca   
Principal Investigator: Robert A Olson         
BC Cancer Agency -Surrey Not yet recruiting
Surrey, British Columbia, Canada
Contact: Devin Schellenberg, MD    604-930-4085    dschellenberg@bccancer.bc.ca   
BC Cancer Recruiting
Vancouver, British Columbia, Canada
Contact: Shilo Lefresne, MD    2506457300    SLefresne@bccancer.bc.ca   
BC Cancer - Victoria Not yet recruiting
Victoria, British Columbia, Canada
Contact: Tanya Berrang, MD    250-519-5577    TBerrang@bccancer.bc.ca   
Canada, Ontario
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada
Contact: Vikram Velter, MD    (519) 685-8500      
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
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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] December 11, 2019

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: February 21, 2020
Last Verified: February 2020

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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:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Neoplasms