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This study compares the use of conventional radiotherapy technique with volumetric intensity-modulated radiotherapy (VMAT) in the treatment of painful cancer metastases. Half of the patients will receive radiotherapy using a conventional technique, while the other half will receive their treatment using a the VMAT technique.
Radiotherapy to painful sites of metastasis can provide pain relief.
Side-effects from radiotherapy is dependent on the volume and dose received by normal tissues. Conventional radiotherapy techniques delivers similar doses of radiation to the targeted cancer lesion and the normal tissues along the entrance and exit paths of the radiation.
Volumetric intensity-modulated arc therapy (VMAT) is an advanced technique of radiotherapy that spares normal tissues from receiving high-dose irradiation. However, VMAT increases the volume of normal tissues receiving low-dose irradiation.
This study aims at comparing the quality of life and side-effect profiles of patients treated by palliative radiotherapy using the conventional technique vs. VMAT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Radiotherapy | Active Comparator | 8Gy in 1 fraction or 20Gy in 5 fractions |
|
| Volumetric Intensity-Modulated Arc Therapy | Experimental | 8Gy in 1 fraction or 20Gy in 5 fractions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volumetric Intensity-Modulated Arc Therapy | Radiation | Advanced radiotherapy technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QOL) | The global QOL subscale will be measured using the European Organization for Research and Treatment of Cancer (EORTC) QLQ C30 questionnaire and compared to baseline. The global QOL subscales will be scored according to the EORTC scoring manual (min: 0, max: 100). Higher scores represent better global QOL. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life - Function subscales | Quality of life function subscales (physical, role, cognitive, emotional, social and financial functions) will be measured using the European Organization for Research and Treatment of Cancer (EORTC) QLQ C30 questionnaire and compared to baseline. QOL subscales will be scored according to the EORTC scoring manual (min: 0, max: 100). For function subscales, higher scores represent better function. |
| Measure | Description | Time Frame |
|---|---|---|
| Resource utilization | Time spent in planning and delivering radiotherapy | Baseline |
| Physical activity | Change in the daily number of steps taken by patients before and after radiotherapy as measured using an activity tracker |
Inclusion Criteria:
Pain (SF-BPI score ≥1) should be related to metastases (bone or others) or to the tumor itself
Capable of providing the full list of analgesic medication being used
Capable of completing the SF-BPI and EORTC questionnaires without any help
Life expectancy of at least 3 month
KPS greater or equal to 50
Radiotherapy to 1 site pain
Site of treatment not previously irradiated
No planned changes in analgesic within 7 days before and after treatment
• Patient may be started on Dexamethasone on the first day of radiotherapy
No planned chemotherapy, radiotherapy or surgery within 7 days before and after treatment
Patient provided informed consent to participate in this study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Wong | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33259935 | Result | Wong P, Lambert L, Thanomsack P, Coulombe G, Lambert C, Charpentier AM, Barkati M, Fortin I, Lafontaine J, Roberge D. Quality of Life: A Prospective Randomized Trial of Palliative Volumetric Arc Therapy Versus 3-Dimensional Conventional Radiation Therapy. Int J Radiat Oncol Biol Phys. 2021 Apr 1;109(5):1431-1439. doi: 10.1016/j.ijrobp.2020.11.061. Epub 2020 Nov 28. | |
| 29383293 |
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Randomized controlled trial
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| Conventional Radiotherapy | Radiation | Conventional radiotherapy technique |
|
| 3 month |
| Quality of Life - Symptom subscales | Quality of life symptom subscales (dyspnea, pain, fatigue, appetite loss, nausea, constipation, and diarrhea symptoms) will be measured using the European Organization for Research and Treatment of Cancer (EORTC) QLQ C30 questionnaire and compared to baseline. QOL subscales will be scored according to the EORTC scoring manual (min: 0, max: 100). For symptom subscales, higher scores represent worse symptoms. | 3 month |
| Pain relief | Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions | 1 week |
| Pain relief | Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions | 1 month |
| Pain relief | Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions | 3 month |
| Toxicities | Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4 | 1 week |
| Toxicities | Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4 | 1 month |
| Toxicities | Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4 | 3 month |
| 1 week |
| Blood biomarkers | Change in cytokine levels in blood following radiotherapy as a biomarker of response to radiotherapy | 1 week |
| Blood biomarkers | Change in circulating microRNA levels in blood following radiotherapy as a biomarker of response to radiotherapy | 1 week |
| Dorion V, Lambert L, Frazzi A, Cayer JF, Wong P. A Pilot Study in the Use of Activity Trackers for Assessing Response to Palliative Radiotherapy. Cureus. 2017 Nov 22;9(11):e1871. doi: 10.7759/cureus.1871. |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D010146 | Pain |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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