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

NCT ID: NCT03374592

Last Updated: 2022-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-07

Study Completion Date

2018-02-21

Brief Summary

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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

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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.

Conditions

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Neoplasm Metastasis Pain Radiotherapy Side Effect Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional Radiotherapy

8Gy in 1 fraction or 20Gy in 5 fractions

Group Type ACTIVE_COMPARATOR

Conventional Radiotherapy

Intervention Type RADIATION

Conventional radiotherapy technique

Volumetric Intensity-Modulated Arc Therapy

8Gy in 1 fraction or 20Gy in 5 fractions

Group Type EXPERIMENTAL

Volumetric Intensity-Modulated Arc Therapy

Intervention Type RADIATION

Advanced radiotherapy technique

Interventions

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Volumetric Intensity-Modulated Arc Therapy

Advanced radiotherapy technique

Intervention Type RADIATION

Conventional Radiotherapy

Conventional radiotherapy technique

Intervention Type RADIATION

Other Intervention Names

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Intensity modulated radiotherapy

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip Wong

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

References

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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.

Reference Type RESULT
PMID: 33259935 (View on PubMed)

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.

Reference Type RESULT
PMID: 29383293 (View on PubMed)

Other Identifiers

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CE14.046

Identifier Type: -

Identifier Source: org_study_id

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