Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT02363218
Eligibility Criteria:
Inclusion Criteria:
1. Confirmed hepatocellular carcinoma according to one of three EASL criteria:
* Histopathology
* Two radiographic techniques (out of US, MRI, CT, Angiography) that confirm a lesion \>2 cm with arterial hypervascularization
* One radiographic technique that confirms a lesion \>2 cm with arterial hypervascularization and an AFP\>400 ng/mL
2. Unifocal liver tumors not to exceed 5 cm in greatest axial dimension. Multifocal lesions will be restricted to a maximum of 3 lesions with a maximum lesion size of 3 cm for each lesion, that can be treated within a single target volume within the same liver segment as long as the dose constraints to normal tissue can be met.
3. Volumn of uninvolved liver \>750 cc
4. Hepatic lesion in patients for whom surgical resection is not possible or patients who refuse surgery.
5. Eastern Clinical Oncology Group (ECOG) performance status 0, 1 or 2 (Appendix I)
6. Patients with liver disease classified as Child Pugh class A
7. Life expectancy \>6 months
8. Age \> 18 years old
9. Albumin \> 2.5 g/dL
10. Total Bilirubin \< 3 mg/dL
11. INR \<1.5
12. Transaminases (SGOT and SGPT) no more than 3 times the upper limit of normal
13. Creatinine \< 2.0 mg/dL
14. Both men and women and members of all races and ethnic groups are eligible for this study
15. Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
1. Prior surgery, chemotherapy or radiation for the liver tumor
2. Prior radiotherapy to the upper abdomen
3. Prior RFA or liver transplant
4. Tumors greater than 5 cm in greatest axial dimension
5. Child B status
6. Contraindication to receiving radiotherapy
7. Active gastrointestinal bleed within 2 weeks of study enrollment
8. Clinically significant ascites refractory to medical therapy
9. Women who are pregnant
10. Administration of any systemic chemotherapy within the last 6 months
11. Presence of multifocal lesions located in different lobes of the liver or extrahepatic metastases
12. Portal vein thrombus
13. Participation in another concurrent treatment protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02363218
Study Brief:
Protocol Section:
NCT02363218