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Trial record 17 of 46397 for:    intensity

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

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ClinicalTrials.gov Identifier: NCT03374592
Recruitment Status : Completed
First Posted : December 15, 2017
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Tracking Information
First Submitted Date  ICMJE December 12, 2017
First Posted Date  ICMJE December 15, 2017
Last Update Posted Date March 26, 2018
Actual Study Start Date  ICMJE July 7, 2014
Actual Primary Completion Date December 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
Quality of Life [ Time Frame: 1 week ]
Global quality of life as measured using the EORTC-QLQ C30 questionnaire
Change History Complete list of historical versions of study NCT03374592 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
  • Quality of Life - Function subscales [ Time Frame: 3 month ]
    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 [ Time Frame: 3 month ]
    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 [ Time Frame: 1 week ]
    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
  • Pain relief [ Time Frame: 1 month ]
    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
  • Pain relief [ Time Frame: 3 month ]
    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
  • Toxicities [ Time Frame: 1 week ]
    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
  • Toxicities [ Time Frame: 1 month ]
    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
  • Toxicities [ Time Frame: 3 month ]
    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
  • Quality of Life [ Time Frame: 1 week ]
    Quality of life subscales as measured using the EORTC-QLQ C30 questionnaire
  • Quality of Life [ Time Frame: 1 month ]
    Quality of life subscales as measured using the EORTC-QLQ C30 questionnaire
  • Quality of Life [ Time Frame: 3 month ]
    Quality of life subscales as measured using the EORTC-QLQ C30 questionnaire
  • Pain relief [ Time Frame: 1 week ]
    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
  • Pain relief [ Time Frame: 1 month ]
    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
  • Pain relief [ Time Frame: 3 month ]
    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
  • Toxicities [ Time Frame: 1 week ]
    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
  • Toxicities [ Time Frame: 1 month ]
    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
  • Toxicities [ Time Frame: 3 month ]
    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
Current Other Pre-specified Outcome Measures
 (submitted: December 12, 2017)
  • Resource utilization [ Time Frame: Baseline ]
    Time spent in planning and delivering radiotherapy
  • Physical activity [ Time Frame: 1 week ]
    Change in the daily number of steps taken by patients before and after radiotherapy as measured using an activity tracker
  • Blood biomarkers [ Time Frame: 1 week ]
    Change in cytokine levels in blood following radiotherapy as a biomarker of response to radiotherapy
  • Blood biomarkers [ Time Frame: 1 week ]
    Change in circulating microRNA levels in blood following radiotherapy as a biomarker of response to radiotherapy
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain
Official Title  ICMJE A Phase II Randomized Controlled Trial of Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Neoplasm Metastasis
  • Pain
  • Radiotherapy Side Effect
  • Quality of Life
Intervention  ICMJE
  • Radiation: Volumetric Intensity-Modulated Arc Therapy
    Advanced radiotherapy technique
    Other Name: Intensity modulated radiotherapy
  • Radiation: Conventional Radiotherapy
    Conventional radiotherapy technique
Study Arms  ICMJE
  • Active Comparator: Conventional Radiotherapy
    8Gy in 1 fraction or 20Gy in 5 fractions
    Intervention: Radiation: Conventional Radiotherapy
  • Experimental: Volumetric Intensity-Modulated Arc Therapy
    8Gy in 1 fraction or 20Gy in 5 fractions
    Intervention: Radiation: Volumetric Intensity-Modulated Arc Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2017)
73
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 21, 2018
Actual Primary Completion Date December 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03374592
Other Study ID Numbers  ICMJE CE14.046
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre hospitalier de l'Université de Montréal (CHUM)
Study Sponsor  ICMJE Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip Wong Centre hospitalier de l'Université de Montréal (CHUM)
PRS Account Centre hospitalier de l'Université de Montréal (CHUM)
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP