Role of high dose radiotherapy in sugically incurable primary liver cancer.
Phase 2
- Conditions
- Health Condition 1: null- Hepatocellular Carcinoma.
- Registration Number
- CTRI/2013/05/003662
- Lead Sponsor
- Regional Cancer Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
1)Patients who are not suitable for standard curative treatments of hepatocellular carcinoma.
2) Histological/cytological diagnosis of hepatocellular carcinoma or a patient with radiologically hyper-vascular liver tumour and a serum alpha-fetoprotein level >400ng/ml without evidence of any other alpha-fetoprotein secreting tumor.
3) Single tumour of size less than or equal to 10cms or two tumours of size less than or equal to 5cms.
4) Child Pugh Class A & B.
5) No evidence of distant metastasis.
6)Informed consent
Exclusion Criteria
1) Pregnancy.
2) Patient who had prior radiotherapy to the treatment area.
3) Other concomitant severe systemic diseases
4)ECOG performance status of 2 or worser.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Assessment of objective response of hepatocellular carcinoma to high dose conformal external beam radiotherapy. <br/ ><br>2)Evaluation of hepatic toxicity to radiotherapy at 6 weeks after radiation <br/ ><br>Timepoint: 6 weeks after completion of radiotherapy.
- Secondary Outcome Measures
Name Time Method Median SurvivalTimepoint: 3 months after radiotherapy