SBRT as a newer technique for treating liver cancers
- Conditions
- Health Condition 1: C220- Liver cell carcinoma
- Registration Number
- CTRI/2022/07/044275
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
-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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ocal 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 Outcome Measures
Name Time Method -Two year overall survival rate Time Frame -from the start of the first treatment until death from any cause. <br/ ><br>-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 <br/ ><br>-Treatment Related Toxicity Time Frame: From start of treatment on every assessment Will be assessed using CTCAE V 5.0 <br/ ><br>-Quality of life assessment using FACT HEP 4 Questionnaire. <br/ ><br>-Progression free survival (PFS) <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 2 years