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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)

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.

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Pain Radiotherapy Side Effect Quality of Life Radiation: Volumetric Intensity-Modulated Arc Therapy Radiation: Conventional Radiotherapy Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Controlled Trial of Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain
Actual Study Start Date : July 7, 2014
Actual Primary Completion Date : December 20, 2017
Actual Study Completion Date : February 21, 2018

Arm Intervention/treatment
Active Comparator: Conventional Radiotherapy
8Gy in 1 fraction or 20Gy in 5 fractions
Radiation: Conventional Radiotherapy
Conventional radiotherapy technique

Experimental: Volumetric Intensity-Modulated Arc Therapy
8Gy in 1 fraction or 20Gy in 5 fractions
Radiation: Volumetric Intensity-Modulated Arc Therapy
Advanced radiotherapy technique
Other Name: Intensity modulated radiotherapy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Pain relief [ Time Frame: 1 week ]
    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions

  4. Pain relief [ Time Frame: 1 month ]
    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions

  5. Pain relief [ Time Frame: 3 month ]
    Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions

  6. Toxicities [ Time Frame: 1 week ]
    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4

  7. Toxicities [ Time Frame: 1 month ]
    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4

  8. Toxicities [ Time Frame: 3 month ]
    Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4


Other Outcome Measures:
  1. Resource utilization [ Time Frame: Baseline ]
    Time spent in planning and delivering radiotherapy

  2. 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

  3. Blood biomarkers [ Time Frame: 1 week ]
    Change in cytokine levels in blood following radiotherapy as a biomarker of response to radiotherapy

  4. Blood biomarkers [ Time Frame: 1 week ]
    Change in circulating microRNA levels in blood following radiotherapy as a biomarker of response to radiotherapy



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374592


Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Philip Wong Centre hospitalier de l'Université de Montréal (CHUM)

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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03374592     History of Changes
Other Study ID Numbers: CE14.046
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Intensity-modulated radiation therapy
Volumetric intensity-modulated arc therapy
Radiotherapy
Pain
Metastasis
Quality of Life
Acute Toxicity
Additional relevant MeSH terms:
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Neoplasm Metastasis
Cancer Pain
Neoplastic Processes
Neoplasms
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms