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

Study Overview
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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.

Official Title
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A Phase II Randomized Controlled Trial of Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain

Conditions
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Neoplasm Metastasis, Pain, Radiotherapy Side Effect, Quality of Life

Intervention / Treatment
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* Radiation: Volumetric Intensity-Modulated Arc Therapy
* Radiation: Conventional Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Radiotherapy<br>8Gy in 1 fraction or 20Gy in 5 fractions | Radiation: Conventional Radiotherapy<br>* Conventional radiotherapy technique<br>|
| Experimental: Volumetric Intensity-Modulated Arc Therapy<br>8Gy in 1 fraction or 20Gy in 5 fractions | Radiation: Volumetric Intensity-Modulated Arc Therapy<br>* Advanced radiotherapy technique<br>* Other names: Intensity modulated radiotherapy;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Intensity-modulated radiation therapy, Volumetric intensity-modulated arc therapy, Pain, Metastasis, Quality of Life, Acute Toxicity