SUPR-3D: Simple Unplanned Palliative Radiotherapy Versus 3D Conformal Radiotherapy for Patients With Bone Metastases
Sponsor:
British Columbia Cancer Agency
Collaborators:
Information provided by (Responsible Party):
Rob Olson，British Columbia Cancer Agency
| Tracking Information | |||
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| First Submitted Date ICMJE | October 1, 2018 | ||
| First Posted Date ICMJE | October 3, 2018 | ||
| Last Update Posted Date | October 3, 2018 | ||
| Actual Study Start Date ICMJE | January 2019 | ||
| Estimated Primary Completion Date | January 2023 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Radiation Induced Nausea and Vomiting[ Time Frame: day 1-5 ] (RINV) as scored in a daily patient diary |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | SUPR-3D: Simple Unplanned Palliative Radiotherapy Versus 3D Conformal Radiotherapy for Patients With Bone Metastases |
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| Official Title ICMJE | SUPR-3D: A Randomized Phase III Trial Comparing Simple Unplanned Palliative Radiotherapy Versus 3D Conformal Radiotherapy for Patients With Bone Metasteses |
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| Brief Summary | The primary objective is to compare patient reported toxicity between standard palliative radiotherapy and VMAT. Secondarily, we will evaluate pain response. However, we hypothesize that there will be no difference in pain response between the two arms, because they are receiving the same dose. |
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| Detailed Description | For this study, SUPR refers to the delivery of radiation to the treatment area with a simple technique, either two opposed fields (parallel opposed pair), or a single direct field. The entire portal is exposed to the specified dose and therefore does not spare normal tissue. This technique requires minimal calculation, and typically the dose distribution is not reviewed by the radiation oncologist or medical physics. In general, the adverse event profile of RT is associated with irradiation of normal tissue within the treatment field. With the dose prescribed in this study, the probability of serious adverse effects is exceedingly low. However, fatigue, soreness, pain flare, and skin-redness in the irradiated area are relatively common adverse events. In addition, site-specific toxicity could occur, including esophagitis, nausea, or diarrhea when there is dose delivered to the GI tract. Avoiding this toxicity is a motivating factor for the study. In order to deliver 3D Conformal Radiotherapy, a CT simulation is used to develop the treatment plan. The goal is to deliver a conformal radiation dose to the target volume with maximal sparing of the normal tissue. VMAT (Volumetric Modulated Arc Therapy is a type of 3D conformal RT, and delivers the radiation dose more conformally than SUPR, possibly reducing acute and late toxicity. The disadvantages of VMAT include more complex planning and quality assurance processes compared with SUPR5. The complex planning required can be time-consuming, which can have a significant impact on departmental resources, and the wait time for the patient. Bone metastases are the most common site of distant metastases and can cause severe and disabling effects, including pain, spinal cord compression and pathologic fracture. These complications can greatly affect a patient's quality of life and cause immense suffering. Radiotherapy (RT) is an effective treatment for palliative patients with painful bone metastases. It is also efficacious in preserving function and maintaining skeletal integrity, while minimizing the occurrence of adverse skeletal related events. There is a significant amount of evidence showing that a single fraction (SF) of RT provides equivalent pain relief as multiple fractions (MF), which are associated with more acute toxicity, are less convenient for patients and costlier for the health care system. Therefore, SFRT is encouraged, but 20 Gy in 5 fractions is also allowed in this study, though should be chosen only in patients with a complicated bone metastases by fracture, neurological deficit (e.g. spinal cord compression), or a large soft tissue component. In patients with advanced disease, management strategies focus on improving quality of life (QOL), rather than conventional endpoints such as survival. Currently, the standard of care in British Columbia for palliative patients with bone metastases is SUPR. In other jurisdictions, however, factors such as physician remuneration make other complex planning techniques more popular. BC Cancer is publicly funded with no direct costs to patients. All RT in the province is provided by 6 centres where radiation oncologists receive an annual salary, which are independent of RT treatment technique and duration. Due to the lack of financial incentive associated with a more complex RT plan, BC Cancer is a unique clinical setting to assess the use of VMAT versus SUPR. As facilities providing RT have gained more experience with VMAT and improvements to VMAT planning software have been made, the planning time required has been reduced. Previously, approximately 2 weeks was required for a team at the BC Cancer to create a VMAT plan for a palliative patient with bone metastases; however, we hypothesize this can now be reduced to three days in settings with low dose prescription. This study will allow us to determine if there is reduced toxicity associated with VMAT compared to SUPR with only a modest impact on resources. Our hypothesis is that VMAT will have reduced toxicity compared with SUPR for palliative patients with bone metastases. We also hypothesize that there will be no difference between the two arms in terms of pain response, due to the fact that the doses are equal. This hypothesis is driven by the radiobiologic rationale, which defines effective RT as the ability of radiation to induce tumour cell death while sparing normal cells. The importance in determining if there is any benefit in terms of toxicity with VMAT compared with SUPR for palliative patients with bone metastases is obvious when consequences related to its adoption are considered. As previously discussed, although the planning time has been drastically reduced, there is still an expected modest increase in resources required to carry out a VMAT plan. For patients, the pre-treatment process of VMAT is more burdensome, i.e. patients have to wait longer before receiving VMAT as compared to SUPR, due to the increased plan complexity. Therefore, it is important to consider the patient experience in relation to the RT administration. In summary, evidence that either supports or refutes the hypothesis that VMAT will have reduced toxicity compared with SUPR for patients with bone metastases will be helpful in guiding future practices. We are not aware of any other randomized control trials (completed or ongoing) that have addressed this issue, though a London Ontario study is randomizing patients receiving palliative lung RT to SUPR vs VMAT. Due to the implications of VMAT on departmental resources and patient experience, better evidence from a randomized control trial is required before the widespread use of this technique can be justified. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | N/A | ||
| Study Design ICMJE | 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: Interventional Masking Description: Primary Purpose: Treatment |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
250 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | January 2028 | ||
| Estimated Primary Completion Date | January 2023 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: - 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 - 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 age - Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaire in either English or French. 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. - Patient must fulfill treatment specific eligibility criteria . Plans not meeting the treatment specific eligibility requirements are not eligible for VMAT Rapid. - No previous treatments requiring EQD2/sum plan constraints - No pacemaker within 10 cm of the RT fields - No contrast required - No mould room necessary (except shells) - No significant hardware within the treatment field - maximum of 2 OARs requiring optimization - For VMAT: PTV volume > 35 cm^3 (2.0 cm radius sphere, roughly 4x4 field) - For SUPR: at least 4x4 field Exclusion Criteria: - Bone metastases being treated is not (at least) partly located in T11 - L5 or pelvis. - Patients whom radiation oncologist is prescribing a dose other than 8 Gy in a single fraction or 20 Gy in 5 fractions. - 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 - Solitary plasmocytoma - Pregnant or lactating women - Target volume cannot be encompassed by a single VMAT isocentre - No custom bolus - Patients requiring treatments outside standard clinical hours | ||
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | Canada | ||
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| Administrative Information | Has Data Monitoring Committee | Yes | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Rob Olson，British Columbia Cancer Agency | ||
| Study Sponsor ICMJE | British Columbia Cancer Agency | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | British Columbia Cancer Agency | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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