protocols

진행프로토콜

PROTOCOLS / 연구참여방법 / 진행프로토콜

피해자 증례현황
시험일련번호 [진행] KROG 14 - 04
임상실험명 수술, 간이식, 국소 소작술이 불가능한 간세포암 환자에서 경동맥화학색전술 단독 치료와 경동맥화학색전술과 정위체부방사선치료 복합 치료를 비교하기 위한 전향적 무작위 3상 임상 연구
시험책임자 김미숙 (한국원자력의학원)
환자적격성 Inclusion Criteria :
1. Pathologically (histologically or cytologically) or radiological proven diagnosis of HCC within 180 days prior to study entry
2. Measureable hepatic disease which may be measureable as per mRECIST on liver CT and MRI within 28 days prior to study entry
3. Appropriate for protocol entry based upon the following minimum diagnostic workup
- History/physical examination, including examination for encephalopathy, ascites, weight, height, and blood pressure within 14 days prior to study entry
- Asessment by radiation oncologist and medical oncologist or hepatologist who specializes in treatment of HCC performed within 28 days prior to study entry
- Pre-randomization Scan (REQUIRED for All Patients): CT scan chest/abdomen/pelvis with multiphasic liver CT scan within 28 days prior to study entry. If CT contrast is contraindicated, CT chest without contrast and MRI of abdomen and pelvis is permitted.
4. ECOG Performance Status 0-1 within 28 days prior to study entry
5. All blood work met the requirements, per the protocol
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³
- Platelets ≥ 75,000 cells/mm³
- Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
- Total bilirubin < 3 mg/dL
- Prothrombin time/INR < 1.7
- Albumin ≥ 2.8 g/L
- AST and ALT < 5 times ULN
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min
6. Esophagogastroduodenoscopy (EGD) within 1 year
7. Age ≥ 20
8. BCLC stage: Stage 0, Early (A) or Intermediate (B) within 14 days prior to study entry
9. Child-Pugh class A within 14 days prior to study entry
10. Normal liver volume (entire liver minus tumor volume) ≥ 700 ml
11. Unsuitable for resection, transplant or radiofrequency ablation (RFA)
12. Women of childbearing potential and male participants must agree to practice adequate contraception while on study and for at least 6 months following the last dose of RT and for at least 28 days following the last dose of TACE (whichever is later).
13. Patient must provide study-specific informed consent prior to study entry

Exclusion Criteria :
1. Total maximal sum of hepatocellular carcinoma > 10 cm
2. More than 3 discrete intrahepatic parenchymal foci of HCC
3. Extrahepatic metastases or malignant nodes
4. Direct tumor extension into the stomach, duodenum, small bowel or large bowel
5. Contraindication for doxorubicin administration
6. Prior radiotherapy to the region of the liver that would result in excessive doses to normal tissues due to overlap of radiation therapy fields
7. Prior selective internal radiotherapy/hepatic arterial Yttrium therapy
8. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years
9. Any of the severe, active co-morbidity
10. Unsuitable for TACE for any of the following reasons (Raoul 2011)
- Technical contraindications: arteriovenous fistula, including transjugular intrahepatic portosystemic shunt (TIPS), surgical portosystemic shunt, spontaneous portosystemic shunt or hepatofugal portal vein flow
- Severe reduction in portal vein flow: due to tumor portal vein, IVC or atrial invasion or bland portal vein occlusion
- Medical contraindications including congestive heart failure, angina, severe peripheral vascular disease
- Other medical comorbidities making TACE (or DEB) unsafe and/or risky (e.g. combination of relative contraindications including age > 80 years, tumor > 10 cm, > 50% replacement of the liver by HCC, extensive multinodular bilobar HCC, biliary drainage)
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KROG 14-04 프로토콜 다운로드.zip (2.1M) (21)
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