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SBRT as a newer technique for treating liver cancers

Not Applicable
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
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

-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
NameTimeMethod
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
NameTimeMethod
-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
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