A Phase II Randomized Controlled Trial of Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 主要终点
- Quality of Life (QOL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Quality of Life (QOL)
时间窗: 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.
次要结局
- Quality of Life - Function subscales(3 month)
- Toxicities(3 month)
- Pain relief(3 month)
- Quality of Life - Symptom subscales(3 month)