NCT07594431招募中2 期
A Randomized Phase II Trial Comparing LATTICE Radiotherapy vs Moderately Dose-escalated Palliative Radiation for Patients With Metastases.
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
研究概览
简要总结
Unblinded, randomized study of 5-fraction LATTICE radiotherapy (20 Gy with an SIB to 66.7 Gy in 5 fractions) versus moderately dose-escalated palliative radiation (25 Gy in 5 fractions)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •80 patients with confirmed metastatic tumor (>2.5 cm in short axis) will be enrolled, all ≥ 12 years of age with ECOG ≤
- •All genders and races will be included.
- •Inclusion Criteria:
- •Histologically, cytologically, or radiographically confirmed diagnosis of metastatic cancer
- •One to two metastases in non-brain sites that are amenable to LATTICE radiotherapy: >2.5 cm in short axis (dimension on axial imaging that is perpendicular to the longest dimension); bone metastasis can be included if the extraosseous component is >2.5 cm in short axis
- •ECOG Performance Status 0-2
- •For patients age 12-16, Lansky Play-Performance score 50-100
- •Negative serum or urine pregnancy test within 2 weeks prior to enrollment of people of childbearing potential
- •All patients and/or their parents or legal guardians must sign a written informed consent. For any child less than 18 years of age, assent must also be obtained in addition to parental or legal guardian consent.
排除标准
- •Prior radiation therapy to the tumor to be treated
- •Active pregnancy
- •Diseases that place the patient at high risk of radiation complications including lupus, scleroderma, Li Fraumeni syndrome
- •The tumor to be treated is from a hematologic malignancy such as lymphoma or myeloma
研究组 & 干预措施
LATTICE Radiotherapy
Experimental
Participants receive 5-fraction LATTICE radiotherapy delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
干预措施: LATTICE Radiotherapy (Radiation)
Standard Radiotherapy
Active Comparator
Participants receive standard radiotherapy (25 Gy in 5 fractions)
干预措施: Standard radiotherapy (Radiation)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
3 期
Lattice Radiation Therapy Versus Conventional Radiation Therapy for the Palliation of Large TumorsNCT07444775University Health Network, Toronto148
已完成
不适用
Fractionated Stereotactic Radiotherapy for Limited Small Volume Brain MetastasesNCT07405047Cancer Institute and Hospital, Chinese Academy of Medical Sciences33
尚未招募
不适用
Comparative study between 2 types of courses of radiotherapy in Post operative female Breast Cancer patients.CTRI/2025/09/094933Mudunuri Lakshmi Priyanka100
尚未招募
2 期
Combination of High and Low-Dose Radiotherapy With Immune Therapy and TKI in Advanced Colorectal Cancer: A Phase II StudyNCT07467590Daping Hospital and the Research Institute of Surgery of the Third Military Medical University33
招募中
2 期
A Prospective Clinical Study on Reduced-intensity Radiotherapy for Stage I/II Low-risk Nasal-type NK/T-cell Lymphoma Achieving Complete Remission After ChemotherapyNCT07628738Ruijin Hospital39