Health Condition 1: null- Hepatocellular cancer
Conditions
Interventions
Intervention1: Stereotactic Body Radiation Therapy: The following techniques contributing to the high precision are used in SBRT: Stereotactic body frame (SBF) with abdominal compression, multimodalit
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: •HCC (biopsy or radiological diagnostic ( >1 cm, enhancing in arterial phase and wash-out in later phases). •Number of lesions: not more than 3 lesions •Lesion size: up to 10 cm for a single lesion (and up to 10 cm cumulative diameter, if there is more than 1 lesion) •Child-Pugh A or B ( •BCLC Stage A/B •Must be fit (eligible) for SBRT and TACE • Unsuitable/unwilling for resection or transplant or radiofrequency ablation (RFA) or if these options are not available •Distance between GTV (lesion) and luminal structures (including esophagus, stomach, duodenum, small or large bowel) is >10 mm •All blood work obtained within 2 weeks prior to study entry with adequate organ function defined as follows: oAbsolute neutrophil count (ANC) >= 1,500 cells/mm3 oPlatelets >=50,000 cells/mm3 oHemoglobin >= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable.) oTotal bilirubin oProthrombin time/INR oAlbumin >= 28 g/L oAST (and ALT) oSerum creatinine = 60 mL/min oMay have had previous surgery, ethanol injection and RFA to the liver
Exclusion criteria
Exclusion criteria: •Not suitable for clinical trial or follow-up •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (Note that carcinoma in situ of the breast, oral cavity, or cervix are all permissible) . No active cancer therapy. •Unsuitable for or refractory to transarterial hepatic chemo-embolization (TACE) Raoul et al (2011) oNon-enhancing HCC on CT or CT-angio or oPortal vein thrombosis/macroscopic venous invasion •Arterio-portal and arterio-venous fistulas observed on pre-study imaging (if it is found during the TACE, the fistula may be embolized before injection of the drug). •Evidence of metastatic disease including nodal or distant metastases. •Previous TACE or radiation to the liver (including SIRT) •Life-threatening condition (including untreated HIV and active hepatitis B/C) oDetectable HBeAg and HBV viral load > 20,000 IU/mL or oHBeAg-negative chronic hepatitis B and HBV viral load >2,000 IU/mL oIf HBV-DNA copy is higher than 500 copies/ml, anti-viral therapy, such as Entecavir followed by observation for 2 weeks. oIf anti-HCV antibody is positive (may be false positive) and increased HCV viral load indicating active disease. Active HCV should be treated sufficiently before inclusion in the study. Below 2 million copies per milliliter (mL) is related to chronic hepatitis C that does not need antiviral therapy. oPatients with active hepatitis B or C should be on treatment for at least 4 weeks before inclusion in the trial •On sorafenib or other antineplastic drug therapy within 7 days before inclusion (not accepted until time of progression). •Pregnancy or women of childbearing potential require a negative pregnancy test within 28 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression at 1 year: local, intra- and extrahepatic progressionTimepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Response rate â?¢Local failure â?? â?¢Intrahepatic failure â?? more than 1 cm from the original tumor volume â?¢Extrahepatic failure â?¢Overall survival â?¢Toxicity â?? consecutive follow-up. â?¢QoL (EORTC QLQC30, EORTC QLQ-HCC18) â?¢Cost-benefit treatment, costs of complication (hospitalization) and patient care/additional therapy for HCC following protocol therapy). Timepoint: 3 year | — |
Countries
Denmark, Egypt, India, Malaysia
Contacts
Public ContactSupriya Sastri nee Chopra
Tata Memorial Hospital
Outcome results
None listed