Health Condition 1: C220- Liver cell carcinoma
Conditions
Interventions
None listed
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: -Histologically or Radiologically proven primary or metastatic liver tumor -Unresectable or Unablatable RFA tumor not amenable to TACE or patient unwilling for it. -Karnofsky Performance Scale KPS equal or greater than 60 -Inclusion criteria for patient may include any of following -Unresectable tumor with Main portal vein thrombus and or tumor invasion into hepatic vein or IVC -Tumor diameter up to 15cm or Less than 5 liver metastases or Multifocal disease including bilobar more than with spared liver vol 700 cc -For metastases the primary tumor site has been adequately treated if metachronous disease and disease-free interval DFI is more than 12 months. -Patients who received prior any Liver Directed Therapy presented with recurrent or residual tumor -Extrahepatic disease which can be included in SBRT volume
Exclusion criteria
Exclusion criteria: -Impossibility to participate at the study procedures due to geographic and social or psychological reasons. -BCLC D and Child Pugh class C and B8-9 -Pregnancy and women under lactation -Patient not consenting for the prospective cohort. -Tumor suitable for ablation that will include -Single lesion less than or equal to 5 cm and deemed suitable for RFA. -For HCC upto 3 lesion less than 3 cm and deemed suitable for RFA. -For metastases upto 5 lesion less than 3 cm and deemed suitable for RFA.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local control rate at 6 months, 12 months, 18 months, 24 months Time Frame: From treatment completion till assessment over 6 months, 12 months, 18 months, 24 months]. Local control is the absence of local failure. Local Failure is defined as evidence of tumor growth/regrowth in any direction beyond that present of the pre-treatment imaging studies in the treated lesionsTimepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| -Two year overall survival rate Time Frame -from the start of the first treatment until death from any cause. -Duration of response- Time from first documented complete or partial response to disease progression or death as per the investigator assessment, RECIST1.1 and mRECIST -Treatment Related Toxicity Time Frame: From start of treatment on every assessment Will be assessed using CTCAE V 5.0 -Quality of life assessment using FACT HEP 4 Questionnaire. -Progression free survival (PFS) Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactDr Rasika sangle
Tata Memorial Centre
Outcome results
None listed