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

NCT03374592 | Completed

• 1 other identifier: CE14.046
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Quality of Life - Function subscales

  3 month

• Quality of Life - Symptom subscales

  3 month

• Pain relief

  1 week

• Pain relief

  1 month

• Pain relief

  3 month

Other Outcomes (4)

• Resource utilization

  Baseline

• Physical activity

  1 week

• Blood biomarkers

  1 week

Study Arms (2)

Conventional Radiotherapy

ACTIVE COMPARATOR

8Gy in 1 fraction or 20Gy in 5 fractions

Radiation: Conventional Radiotherapy

Volumetric Intensity-Modulated Arc Therapy

EXPERIMENTAL

8Gy in 1 fraction or 20Gy in 5 fractions

Radiation: Volumetric Intensity-Modulated Arc Therapy

Interventions

Volumetric Intensity-Modulated Arc Therapy RADIATION

Advanced radiotherapy technique

Also known as: Intensity modulated radiotherapy

Volumetric Intensity-Modulated Arc Therapy

Conventional Radiotherapy RADIATION

Conventional radiotherapy technique

Conventional Radiotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Related Publications (2)

• 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.

  PMID: 33259935 RESULT

• 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.

  PMID: 29383293 RESULT

MeSH Terms

Conditions

Neoplasm Metastasis; Pain; Radiation Injuries

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Philip Wong

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 15, 2017
• Study Start: July 7, 2014
• Primary Completion: December 20, 2017
• Study Completion: February 21, 2018
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share