External Beam Radiotherapy for Unresectable Hepatocellular Carcinoma. A Multicenter Phase I/II Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 12
- 主要终点
- Dose-limiting toxicity (Phase I)
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. This may be an effective treatment for liver cancer.
PURPOSE: This phase I/II trial is studying the side effects and best dose of external-beam radiation therapy in treating patients with liver cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
- To assess the feasibility and safety of radiotherapy (RT) in patients with hepatocellular carcinoma. (Phase I)
- To assess the safety and efficacy of RT in these patients. (Phase II)
- To generate reproducible peptide patterns of the serum proteome or specific serum sub proteomes in these patients.
- To assess changes in the proteome or sub proteome patterns after RT in these patients.
- To detect peptides that discriminate between before and after RT in these patients.
- To identify these discriminating peptides in these patients.
OUTLINE: This is a multicenter, phase I dose-escalation study followed by a phase II study.
Patients undergo radiotherapy (RT) once daily, five days a week, for 6 weeks. Intensity-modulated, 3-dimensional conformal, or fractionated stereotactic RT may be used.
After completion of study therapy, patients in the phase I portion are followed for 1 year and patients in the phase II portion are followed for 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Radiation: 3-dimensional conformal radiation therapy
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Radiation: 3-dimensional conformal radiation therapy
干预措施: intensity-modulated radiation therapy (Radiation)
Radiation: 3-dimensional conformal radiation therapy
干预措施: stereotactic body radiation therapy (Radiation)
结局指标
主要结局
Dose-limiting toxicity (Phase I)
时间窗: during RT or within 30 days after the last RT dose, is a DLT.
Best objective response of target liver lesions (TLLs)
时间窗: according to RECIST criteria for up to 1 year after completion of study therapy (Phase II)
次要结局
- Best objective response of TLLs according to RECIST criteria (Phase I)(according to RECIST criteria (Phase I))
- Volumetric response of TLLs(at 5 months after completion of study therapy (Phase II))
- Child-Pugh Score(at last study visit and at 1, 2, 3, and 5 months after completion of study therapy (Phase II))
- Serum alpha-fetoprotein level (Phase II)(will be measured until progression, if AFP is ≥ 1.5 x ULN at baseline.)
- Adverse events according to NCI CTCAE v.3.0(during therapy and within 3 months after completion of study therapy (Phases I and II))
- Time to progression of TLLs (Phase II)(calculated from registration until documented tumor progression of target liver lesions.)
- Duration of response of TLLs (Phase II)(the time from achieving an objective response (CR + PR) to a progression of target liver lesions according to RECIST or death.)
- Stable disease of TLLs (Phase II)(will be determined according to RECIST)
- Progression-free survival (Phase II)(calculated from registration until documented tumor progression or death, whichever occurs first.)
- Compensatory liver tissue hypertrophy at baseline and at 5 months after completion of study therapy (Phase II)(Increase in residual liver volume (= total liver - GTV) (ml) between registration and 5 months after RT will be calculated)
- Time to liver event (Phase II)(from registration until progressive liver disease.)
- Overall survival (Phase II)(calculated from registration until death)