NCT00777894已完成1 期
External Beam Radiotherapy for Unresectable Hepatocellular Carcinoma. A Multicenter Phase I/II Trial.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 6
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically, cytologically, or radiologically confirmed hepatocellular carcinoma
- •Clinical stage T2-4, N0-1, M0 (stage II, IIIA, IIIB, IIIC) OR unresectable T1, N0-1, M0 (stage I) disease
- •M1 disease allowed in phase I if at least 90% of the tumor load (volume) is in the liver
- •Measurable disease (at least one liver lesion that can be measured in at least one dimension as ≥ 10 mm in multislice CT scan/MRI)
- •Volumetry of liver tumor and residual liver tissue: residual liver volume (= total liver volume - gross tumor volume) has to be ≥ 800 mL and ≥ 40% of total liver volume
- •No operable disease (with curative intent or planned liver transplantation)
- •No presence of clinical ascites
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Cirrhosis Child-Pugh class A or B (Child-Pugh score of ≤ 9)
- •Hemoglobin ≥ 100 g/L
- •ANC ≥ 1,200/mm³
- •Platelet count ≥ 50,000/mm³
- •ALT and AST ≤ 7 times upper limit of normal (ULN)
- •AP ≤ 10 times ULN
- •Bilirubin ≤ 50 μmol/L
- •Creatinine clearance ≥ 50 mL/min
- •Functional left kidney (scintigraphy mandatory for phase I, phase II only if indicated)
- •Lipase ≤ 2 times ULN (phase I only)
- •Able to tolerate proton-pump inhibitors or H2 antagonists during radiation therapy
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 4 months after completion of study therapy
- •No prior malignancy allowed, except for the following:
- •Adequately treated cervical carcinoma in situ
- •Adequately treated localized nonmelanoma skin cancer
- •Any other malignancy from which patient has been disease-free for 5 years
- •No presence of medically uncontrolled encephalopathy
- •No myocardial infarction within the past 6 months
- •No esophageal varices ≥ grade 3, with red signs, or bleeding within the past 3 months
- •No symptoms of colitis, enteritis, esophagitis, fistula, gastritis, ileus, necrosis, perforation, stricture, or ulcer
- •No severe anorexia, constipation, dehydration, diarrhea, or vomiting
- •No serious underlying medical condition that, in the opinion in the investigator, would preclude study participation (e.g., active autoimmune disease or uncontrolled diabetes)
- •Portal vein thrombosis allowed
- •No psychiatric disorder precluding understanding of information on study related topics or giving informed consent
- •No nutritional intake < 1500 calories per day (corrected)
- •No weight loss ≥ 15 % within the past 3 months
- •PRIOR CONCURRENT THERAPY:
- •At least 8 weeks since prior transarterial chemoembolization (TACE), radiofrequency ablation, or radiotherapy (RT) unless progressive disease was documented after this therapy
- •At least 21 days since prior and no other concurrent treatment with experimental drugs
- •At least 21 days since prior and no other concurrent treatment on another clinical trial
- •At least 21 days since prior and no other concurrent anticancer therapy
- •No prior RT to the abdomen or caudal chest
- •Prior RT to pelvis allowed
- •Prior RT to chest must be above D5 vertebra
- •Portal vein embolization ligation or pre-RT TACE allowed
- •No concurrent treatment with steroids or non-steroidal anti-inflammatory drugs during RT (proton-pump inhibitor allowed)
排除标准
- 未提供
研究组 & 干预措施
Radiation: 3-dimensional conformal radiation therapy
Experimental
干预措施: intensity-modulated radiation therapy (Radiation)
Radiation: 3-dimensional conformal radiation therapy
Experimental
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Radiation: 3-dimensional conformal radiation therapy
Experimental
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
- 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 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.)
- Serum alpha-fetoprotein level (Phase II)(will be measured until progression, if AFP is ≥ 1.5 x ULN at baseline.)
- 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))
- 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 liver event (Phase II)(from registration until progressive liver disease.)
- Overall survival (Phase II)(calculated from registration until death)
研究者
研究点 (6)
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