Neoplasm MetastasisNCT03374592
Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain
A study testing Volumetric Intensity-Modulated Arc Therapy and Conventional Radiotherapy in people with Neoplasm Metastasis and Pain, run by Centre hospitalier de l'Université de Montréal (CHUM).
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasm Metastasis, Pain, Radiotherapy Side Effect
- What is being tested?
- Volumetric Intensity-Modulated Arc Therapy and Conventional Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- 7 Jul 2014to 21 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- Major mental or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up.
- Treatment to upper and lower limb
- Treatment to 2 or more sites of pain
- Re-irradiation of the site of treatment
- Women who are pregnant
- Life expectancy less than 3 month
About this study
Official title: A Phase II Randomized Controlled Trial of Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain
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.
Read the detailed description
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.
- Conditions
- Neoplasm Metastasis, Pain, Radiotherapy Side Effect, Quality of Life
- Being tested
- Volumetric Intensity-Modulated Arc Therapy, Conventional Radiotherapy
- Keywords
- Intensity-modulated radiation therapy, Volumetric intensity-modulated arc therapy, Radiotherapy, Pain, Metastasis, Quality of Life, Acute Toxicity
- Medical subject headings
- Neoplasm Metastasis, Pain, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volumetric Intensity-Modulated Arc TherapyRadiation
Also called Intensity modulated radiotherapy
Advanced radiotherapy technique
Conventional RadiotherapyRadiation
Conventional radiotherapy technique
| Study group | Role | What they receive |
|---|---|---|
| Conventional Radiotherapy | Active comparator | 8Gy in 1 fraction or 20Gy in 5 fractions Receives: Radiation: Conventional Radiotherapy |
| Volumetric Intensity-Modulated Arc Therapy | Experimental | 8Gy in 1 fraction or 20Gy in 5 fractions Receives: Radiation: Volumetric Intensity-Modulated Arc Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (8)
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.
Measured: 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.
Measured: 3 month
Pain relief
Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
Measured: 1 week
Pain relief
Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
Measured: 1 month
Pain relief
Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
Measured: 3 month
Toxicities
Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
Measured: 1 week
Toxicities
Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
Measured: 1 month
Toxicities
Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start7 Jul 2014
- Primary completion20 Dec 2017
- Study completion21 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip Wong, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374592
- Sponsor's protocol ID
- CE14.046
- Status last verified
- Nov 2022
- First submitted
- 12 Dec 2017
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33259935Dorion 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.
PubMed 29383293
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Controlled Trial of Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain
- ClinicalTrials.gov ID
- NCT03374592
- Acronym / sponsor ID
- CE14.046
- Conditions
- Neoplasm Metastasis, Pain, Radiotherapy Side Effect, Quality of Life
- Keywords
- Intensity-modulated radiation therapy, Volumetric intensity-modulated arc therapy, Radiotherapy, Pain, Metastasis, Quality of Life, Acute Toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 7 Jul 2014 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 21 Feb 2018 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Conventional Radiotherapy | Active comparator | Radiation: Conventional Radiotherapy8Gy in 1 fraction or 20Gy in 5 fractions |
| Volumetric Intensity-Modulated Arc Therapy | Experimental | Radiation: Volumetric Intensity-Modulated Arc Therapy8Gy in 1 fraction or 20Gy in 5 fractions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- Major mental or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up.
- Treatment to upper and lower limb
- Treatment to 2 or more sites of pain
- Re-irradiation of the site of treatment
- Women who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volumetric Intensity-Modulated Arc TherapyAlso: Intensity modulated radiotherapyAdvanced radiotherapy technique | Radiation | Volumetric Intensity-Modulated Arc Therapy |
| Conventional RadiotherapyConventional radiotherapy technique | Radiation | Conventional Radiotherapy |
Primary outcome
Quality of Life (QOL)
Time frame: 1 week
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.
8 secondary outcomes
Quality of Life - Function subscales
Time frame: 3 month
Quality of Life - Symptom subscales
Time frame: 3 month
Pain relief
Time frame: 1 week
Pain relief
Time frame: 1 month
Pain relief
Time frame: 3 month
Toxicities
Time frame: 1 week
Toxicities
Time frame: 1 month
Toxicities
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Results publication: PubMed 33259935Wong 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.
- Results publication: PubMed 29383293Dorion 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Wong principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Questions about this trial
What is this clinical trial studying?
A study testing Volumetric Intensity-Modulated Arc Therapy and Conventional Radiotherapy in people with Neoplasm Metastasis and Pain, run by Centre hospitalier de l'Université de Montréal (CHUM).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QOL) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03374592, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.