An interventional study of Volumetric Intensity-Modulated Arc Therapy and Conventional Radiotherapy in Neoplasm Metastasis, Pain and Radiotherapy Side Effect, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed. Per ClinicalTrials.gov, last updated 2022-11-16.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment
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.
4,043 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's enrollment of 73 is above the median of 50 across 3,269 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
No planned changes in analgesic within 7 days before and after treatment
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
8Gy in 1 fraction or 20Gy in 5 fractions
Radiation: Conventional Radiotherapy
8Gy in 1 fraction or 20Gy in 5 fractions
Radiation: Volumetric Intensity-Modulated Arc Therapy
Advanced radiotherapy technique
Also known as: Intensity modulated radiotherapy
Conventional radiotherapy technique
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.
Time frame: 1 week
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.
Time frame: 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.
Time frame: 3 month
Pain relief
Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
Time frame: 1 week
Pain relief
Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
Time frame: 1 month
Pain relief
Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
Time frame: 3 month
Toxicities
Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
Time frame: 1 week
Toxicities
Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
Time frame: 1 month
Toxicities
Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
Time frame: 3 month
Resource utilization
Time spent in planning and delivering radiotherapy
Time frame: Baseline
Physical activity
Change in the daily number of steps taken by patients before and after radiotherapy as measured using an activity tracker
Time frame: 1 week
Blood biomarkers
Change in cytokine levels in blood following radiotherapy as a biomarker of response to radiotherapy
Time frame: 1 week
Blood biomarkers
Change in circulating microRNA levels in blood following radiotherapy as a biomarker of response to radiotherapy
Time frame: 1 week
No study locations are listed for this record.
Plan to share: No
Ran from Jul 2014 to primary completion in Dec 2017, 41 months.
Of 291 non-industry interventional studies with no phase under Neoplasm Metastasis, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 93. This study's 41 months is below that.
Counting every sponsor, half of 316 studies reached it within 54 months; a quarter within 28 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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