Radiation Therapy as Palliative Treatment of GIST Progressing During or After Tyrosine Kinase Inhibitor Therapy: A Prospective Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Target tumor response rate
研究概览
简要总结
Gastrointestinal stromal tumors (GISTs) are generally considered resistant to radiation, but no prospective trials addressing efficacy and tolerability of radiation therapy have been carried out. Limited clinical experience suggests that selected GIST patients may benefit from palliative radiation therapy. The purpose of this prospective, non-randomized, multicenter study is to evaluate efficacy and safety of palliative radiation therapy in GIST patients who have progressive GIST during or after tyrosine kinase inhibitor therapy.
详细描述
Radiation therapy planning must be based on computerized tomography (CT). External beam radiation must be used. Both 3D and IMRT plans are acceptable. The cumulative radiation dose may range from 30 to 40 Gy as administered in 1.8 to 2.0 Gy fractions, 5 fractions per week. The dose is specified as defined by the ICRU (International Commission on Radiation Units and Measurements) report 50. Response is evaluated using CT 6 and 12 weeks after irradiation. Adverse effects are evaluated using the Common Terminology Criteria for Adverse Effects (CTCAE)version 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically verified GIST.
- •Metastatic or locally advanced, inoperable disease.
- •Adequate systemic treatment has been administered.
- •One or more growing GIST metastasis present during of after TKI therapy.
- •The target lesion(s) is measurable.
- •A written informed consent
排除标准
- •WHO performance status is
- •Estimated life-expectancy less than 3 months.
- •Radiation planning target volume greater than 3 dm
- •Unmeasurable target lesion. Bone and brain metastases are not accepted target lesions.
- •Radiation therapy cannot be delivered (e.g. active infection or restlessness.)
- •Pregnancy.
- •Systemic GIST treatment with unknown efficacy.
- •Copies of CT images cannot be sent for central review.
研究组 & 干预措施
Radiotherapy
GIST patients who have progressing metastases will be treated with radiotherapy.
干预措施: Radiation therapy (external beam photons) (Radiation)
结局指标
主要结局
Target tumor response rate
时间窗: 6 to 12 weeks
次要结局
- Time to progression of irradiated lesions(6 months)
- Time to progression of GIST(6 months)
- Control of GIST-related symptoms(6 months)
- Adverse effects of radiation therapy(6 months)
研究者
Heikki Joensuu
Professor
University of Helsinki