Clinical trial NCT03374592: Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain
Official title: A Phase II Randomized Controlled Trial of Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 73
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Quality of Life (QOL)
timeFrame: 1 week
Secondary outcomes:
measure: Quality of Life - Function subscales
timeFrame: 3 month
measure: Quality of Life - Symptom subscales
timeFrame: 3 month
measure: Pain relief
timeFrame: 1 week
measure: Pain relief
timeFrame: 1 month
measure: Pain relief
timeFrame: 3 month
measure: Toxicities
timeFrame: 1 week
measure: Toxicities
timeFrame: 1 month
measure: Toxicities
timeFrame: 3 month
Other outcomes:
measure: Resource utilization
timeFrame: Baseline
measure: Physical activity
timeFrame: 1 week
measure: Blood biomarkers
timeFrame: 1 week
measure: Blood biomarkers
timeFrame: 1 week
Locations:
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Philip Wong
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.