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

Not Applicable

Completed

• Conditions: Neoplasm Metastasis; Quality of Life; Pain; Radiotherapy Side Effect
• Interventions: Radiation: Conventional Radiotherapy; Radiation: Volumetric Intensity-Modulated Arc Therapy

• Registration Number: NCT03374592
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-07-07
• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-15
• Primary Completion: 2017-12-20
• Study Completion: 2018-02-21
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Radiotherapy	Conventional Radiotherapy	8Gy in 1 fraction or 20Gy in 5 fractions
Volumetric Intensity-Modulated Arc Therapy	Volumetric Intensity-Modulated Arc Therapy	8Gy in 1 fraction or 20Gy in 5 fractions

Primary Outcome Measures

Name	Time	Method
Quality of Life (QOL)	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

Name	Time	Method
Quality of Life - Function subscales	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.
Toxicities	3 month	Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4
Pain relief	3 month	Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions
Quality of Life - Symptom subscales	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.