Neoplasms Clinical Trial
Official title:
SUPR-3D: A Randomized Phase III Trial Comparing Simple Unplanned Palliative Radiotherapy Versus 3D Conformal Radiotherapy for Patients With Bone Metastases
NCT number | NCT03694015 |
Other study ID # | SUPR-3D |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2, 2019 |
Est. completion date | June 2024 |
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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. - 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 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 (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. |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre | London | Ontario |
Canada | BC Cancer | Prince George | British Columbia |
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
Canada | BC Cancer | Vancouver | British Columbia |
Canada | BC Cancer - Victoria | Victoria | British Columbia |
Lead Sponsor | Collaborator |
---|---|
British Columbia Cancer Agency |
Canada,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Webb S. Advances in treatment with intensity-modulated conformal radiotherapy. Tumori. 1998 Mar-Apr;84(2):112-26. doi: 10.1177/030089169808400206. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Control of RINV Radiation Induced Nausea and Vomiting (RINV) | as measured by a daily patient diary (day 1-5) | day 1-5 | |
Secondary | Patient Reported Pain Response | as measured by the Brief Pain Inventory | baseline, 2 weeks, and 4 weeks post treatment | |
Secondary | Patient Reported Use of Medications | as measured by the Patient Diary | baseline, 2 weeks, and 4 weeks post treatment | |
Secondary | Patient Reported Fatigue, Nausea, Vomiting | as measured by the PRO-CTCAE | baseline, 2 weeks, and 4 weeks post treatment | |
Secondary | Patient Reported Quality of Life | as measured by EORTC QLQ C-15 PAL | baseline, 2 weeks, and 4 weeks post treatment | |
Secondary | Economic Analysis | as measured by EQ-5D-5L | baseline, 2 weeks, and 4 weeks post treatment |
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