Prospective collection of data of patients with liver cancers being treated with proton therapy

Not Applicable

• Conditions: Health Condition 1: C228- Malignant neoplasm of liver, primary, unspecified as to type

• Registration Number: CTRI/2020/12/030087
• Lead Sponsor: Apollo Proton Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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 <= 4 times the institutional upper limit of normal

d. Transaminases (AST/ALT) <= 6 times the institutional upper limit of normal.

e. Serum creatinine <= 2 mg/dl.

4. Patients who have the ability to understand and be willing to sign a written informed consent document

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified