Health Condition 1: C228- Malignant neoplasm of liver, primary, unspecified as to type
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
Apollo Proton Cancer Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients 18years or older with histological or radiologic diagnosis of hepatocellular carcinoma, intrahepatic cholangiocarcinoma or mixed histology 2. Patients either deemed unresectable and/or locally recurrent OR who require bridging/down staging to orthotopic liver transplant OR who have tumour recurrence in a transplanted liver OR patients with any macrovascular invasion (tumour thrombosis of main portal vein, branch portal vein, segmental portal vein or hepatic vein, inferior vena cava). 3. Patients must have normal organ and marrow function as defined below: a. Absolute neutrophil count >=750 cells/μL b. Platelets >= 50,000 / μL c. Total bilirubin d. Transaminases (AST/ALT) e. Serum creatinine 4. Patients who have the ability to understand and be willing to sign a written informed consent document
Exclusion criteria
Exclusion criteria: 1. Patients with extra hepatic disease (M1) except oligometastatic disease and intravascular tumour thrombosis. 2. Patients with more than 7 tumours, except closely conglomerated lesions/satellite lesions. 3. Performance status of ECOG 3 or more. 4. Patients with Child Pugh score 10 or more, i.e. Child- Pugh Class C, except if patient is on anti-coagulant like warfarin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To report the proportion of patients developing decline in liver function at 1 and 3 months after proton beam therapy and the patient, tumour and treatment factors influencing this.Timepoint: To report the proportion of patients developing decline in liver function at 1 and 3 months after proton beam therapy and the patient, tumour and treatment factors influencing this. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the overall survival and progression free survival as well as rates of patients at 2 years after proton therapyTimepoint: 2 years after proton therapy;To document the trends in quality of life of all patients using site-specific questionnaires: o EORTC-QLQ-C30 , o EORTC-QLQ-HCC18 , o EORTC-QLQ-BIL21Timepoint: pre-treatment, post-treatment, 3 monthly, 6 monthly, 1 year, 2 year after treatment;To estimate the rate of local control of irradiated lesions at 2 years post therapy, according to mRECIST criteria and RECIST 1.1 criteria.Timepoint: 2 years post therapy;To estimate the time to progression of irradiated hepatic lesion according to mRECIST criteriaTimepoint: 1 year;To report the proportion of patients with â?¥ Grade 2 toxicity to stomach, duodenum, small and large bowel, chest wall, skin, fatigue, nausea as well as biochemical parameters of liver function anytime within the first year after proton beam therapy, as per CTCAE (Version 5.0)criteria.Timepoint: weekly during treatment, 3 monthly, 6 monthly, 1 year, 2 year after treatment | — |
Countries
India
Contacts
Public ContactAshwathy Susan Mathew
Apollo Proton Cancer Centre
Outcome results
None listed