- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00109954
Hepatic Arterial Chemoembolization With Cisplatin or Internal Radiation Therapy in Treating Patients With Advanced Liver Cancer That Cannot Be Removed By Surgery
A Prospectively Randomized Controlled Clinical Trial Comparing TheraSphere With Cisplatin-Based TACE (Trans Arterial Chemo Embolization) in the Management of Advanced Stage, Unresectable Hepatocellular Carcinoma (HCC)
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. In this case, chemotherapy is given through the artery (hepatic artery) that brings blood to the tumor. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether hepatic arterial chemoembolization with cisplatin is more effective than internal radiation therapy in treating liver cancer.
PURPOSE: This randomized phase III trial is studying hepatic arterial chemoembolization with cisplatin to see how well it works compared to internal radiation therapy in treating patients with advanced liver cancer that cannot be removed by surgery.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Compare time to disease progression in patients with unresectable advanced hepatocellular carcinoma treated with cisplatin-based trans-arterial chemoembolization vs hepatic intra-arterial yttrium Y 90 glass microspheres (TheraSphere®).
- Compare the health-related quality of life of patients treated with these regimens.
- Compare the safety of these regimens in these patients.
Secondary
- Compare survival of patients treated with these regimens.
- Compare tumor response by CT scan in patients treated with these regimens.
- Compare treatment-related costs, in terms of cost of therapy and number of hospitalization days, in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to extent of tumor in the liver (< 50% vs ≥ 50%) and presence of portal hypertension (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo trans-arterial chemoembolization comprising intra-arterial (IA) infusion of cisplatin over 30-60 minutes followed by embolization of the hepatic artery (that brings blood to the tumor) on day 1. Treatment repeats every 8-10 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive yttrium Y 90 glass microspheres (TheraSphere®) IA on day 1. Beginning 60 days after the first TheraSphere® treatment, patients may receive additional treatment with TheraSphere® only if follow-up CT scans show progressive disease.
Quality of life is assessed at baseline and then every 3 months thereafter.
After the completion of study treatment, patients are followed at 30 days and then every 2 months for 2 years.
PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15232
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Histologically or cytologically confirmed hepatocellular carcinoma (HCC)
- Confined to the liver
Vascular liver mass in the presence of cirrhosis
- Alpha-fetoprotein level > 500 ng/mL
Measurable disease
- At least 1 unidimensionally measurable lesion > 20 mm by spiral CT scan
- Unresectable disease, due to tumor size or extent or presence of cirrhosis
No metastatic disease, including brain metastases
- Locoregional lymph node metastases allowed
- No evidence of potential delivery of > 16.5 miCi (30 Gy absorbed dose) of radiotherapy to the lungs either during the first administration of yttrium Y 90 glass microspheres (TheraSphere®) or on cumulative delivery of radiation to the lungs over multiple treatments*
- No evidence of detectable technetium Tc 99m macroaggregated albumin (Tc-99m MAA) flow to the stomach or duodenum after application of established angiographic techniques to stop the flow* NOTE: *For patients randomized to the TheraSphere® arm only
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- More than 12 weeks
Hematopoietic
- WBC > 2,500/mm^3
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 60,000/mm^3
- No bleeding diathesis not correctable by usual forms of therapy
Hepatic
- See Disease Characteristics
- Bilirubin < 2.0 mg/dL
- AST and/or ALT ≤ 5 times upper limit of normal
- Hepatitis allowed
- No portal hypertension with hepatofugal flow
Renal
- Creatinine < 2.5 mg/dL
Cardiovascular
- No symptomatic congestive heart failure
- No severe peripheral vascular disease that would preclude catheterization
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double barrier or hormonal contraception during and for at least 30 days after completion of study treatment
- No ongoing or active infection
- No other uncontrolled illness
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No more than 1 prior systemic chemotherapy for HCC
- More than 4 weeks since prior IV chemotherapy and recovered
- More than 1 year since prior hepatic arterial cisplatin
- More than 4 months since other prior hepatic arterial chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior external hepatic radiotherapy for HCC
Surgery
- Not specified
Other
- No other concurrent therapy for HCC
- No other concurrent investigational agents
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
---|
Progression-free survival as assessed by tumor progression in the treated lobe of the liver
|
Health-related quality of life at baseline and every 3 months
|
Toxicity as measured by NCI CTCAE version 3.0
|
공동 작업자 및 조사자
수사관
- 연구 의자: Brian I. Carr, MD, University of Pittsburgh
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PCI-04128
- CDR0000425333 (레지스트리 식별자: PDQ (Physician Data Query))
- PCI-IRB-0501021
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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