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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Pain; Neoplasm Metastasis; Radiotherapy Side Effect
• Intervention / Treatment: Radiation: Conventional Radiotherapy; Radiation: Volumetric Intensity-Modulated Arc Therapy

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: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Intensity modulated radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 month
Pain relief	Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions	1 week
Pain relief	Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions	1 month
Pain relief	Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions	3 month
Toxicities	Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4	1 week
Toxicities	Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4	1 month
Toxicities	Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4	3 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resource utilization	Time spent in planning and delivering radiotherapy	Baseline
Physical activity	Change in the daily number of steps taken by patients before and after radiotherapy as measured using an activity tracker	1 week
Blood biomarkers	Change in cytokine levels in blood following radiotherapy as a biomarker of response to radiotherapy	1 week
Blood biomarkers	Change in circulating microRNA levels in blood following radiotherapy as a biomarker of response to radiotherapy	1 week

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Philip Wong, Centre Hospitalier de l'Universite de Montreal (CHUM)

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2014
• Primary Completion (Actual): December 20, 2017
• Study Completion (Actual): February 21, 2018

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 15, 2017

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Quality of Life; Pain; Radiotherapy; Metastasis; Intensity-modulated radiation therapy; Volumetric intensity-modulated arc therapy; Acute Toxicity
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Pain; Neurologic Manifestations; Neoplastic Processes; Neoplasm Metastasis; Cancer Pain
• Other Study ID Numbers: CE14.046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No