search
Back to results

Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain

Primary Purpose

Neoplasm Metastasis, Pain, Radiotherapy Side Effect

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Volumetric Intensity-Modulated Arc Therapy
Conventional Radiotherapy
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm Metastasis focused on measuring Intensity-modulated radiation therapy, Volumetric intensity-modulated arc therapy, Radiotherapy, Pain, Metastasis, Quality of Life, Acute Toxicity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pain (SF-BPI score ≥1) should be related to metastases (bone or others) or to the tumor itself
  2. Capable of providing the full list of analgesic medication being used
  3. Capable of completing the SF-BPI and EORTC questionnaires without any help
  4. Life expectancy of at least 3 month
  5. KPS greater or equal to 50
  6. Radiotherapy to 1 site pain
  7. Site of treatment not previously irradiated

  8. No planned changes in analgesic within 7 days before and after treatment

    • Patient may be started on Dexamethasone on the first day of radiotherapy

  9. No planned chemotherapy, radiotherapy or surgery within 7 days before and after treatment
  10. Patient provided informed consent to participate in this study

Exclusion Criteria:

  1. 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.
  2. Treatment to upper and lower limb
  3. Treatment to 2 or more sites of pain
  4. Re-irradiation of the site of treatment
  5. Women who are pregnant
  6. Life expectancy less than 3 month

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Conventional Radiotherapy

    Volumetric Intensity-Modulated Arc Therapy

    Arm Description

    8Gy in 1 fraction or 20Gy in 5 fractions

    8Gy in 1 fraction or 20Gy in 5 fractions

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    Pain relief
    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
    Pain relief
    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
    Pain relief
    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
    Toxicities
    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
    Toxicities
    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
    Toxicities
    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4

    Full Information

    First Posted
    December 12, 2017
    Last Updated
    November 14, 2022
    Sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03374592
    Brief Title
    Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain
    Official Title
    A Phase II Randomized Controlled Trial of Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    July 7, 2014 (Actual)
    Primary Completion Date
    December 20, 2017 (Actual)
    Study Completion Date
    February 21, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled trial
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    73 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional Radiotherapy
    Arm Type
    Active Comparator
    Arm Description
    8Gy in 1 fraction or 20Gy in 5 fractions
    Arm Title
    Volumetric Intensity-Modulated Arc Therapy
    Arm Type
    Experimental
    Arm Description
    8Gy in 1 fraction or 20Gy in 5 fractions
    Intervention Type
    Radiation
    Intervention Name(s)
    Volumetric Intensity-Modulated Arc Therapy
    Other Intervention Name(s)
    Intensity modulated radiotherapy
    Intervention Description
    Advanced radiotherapy technique
    Intervention Type
    Radiation
    Intervention Name(s)
    Conventional Radiotherapy
    Intervention Description
    Conventional radiotherapy technique
    Primary Outcome Measure Information:
    Title
    Quality of Life (QOL)
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Quality of Life - Function subscales
    Description
    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
    Title
    Quality of Life - Symptom subscales
    Description
    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
    Title
    Pain relief
    Description
    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
    Time Frame
    1 week
    Title
    Pain relief
    Description
    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
    Time Frame
    1 month
    Title
    Pain relief
    Description
    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
    Time Frame
    3 month
    Title
    Toxicities
    Description
    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
    Time Frame
    1 week
    Title
    Toxicities
    Description
    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
    Time Frame
    1 month
    Title
    Toxicities
    Description
    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
    Time Frame
    3 month
    Other Pre-specified Outcome Measures:
    Title
    Resource utilization
    Description
    Time spent in planning and delivering radiotherapy
    Time Frame
    Baseline
    Title
    Physical activity
    Description
    Change in the daily number of steps taken by patients before and after radiotherapy as measured using an activity tracker
    Time Frame
    1 week
    Title
    Blood biomarkers
    Description
    Change in cytokine levels in blood following radiotherapy as a biomarker of response to radiotherapy
    Time Frame
    1 week
    Title
    Blood biomarkers
    Description
    Change in circulating microRNA levels in blood following radiotherapy as a biomarker of response to radiotherapy
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Philip Wong
    Organizational Affiliation
    Centre hospitalier de l'Université de Montréal (CHUM)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33259935
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    29383293
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

    Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain

    We'll reach out to this number within 24 hrs