Liver Cancer Clinical Trial
Official title:
External Beam Radiotherapy for Unresectable Hepatocellular Carcinoma. A Multicenter Phase I/II Trial.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. This may be an
effective treatment for liver cancer.
PURPOSE: This phase I/II trial is studying the side effects and best dose of external-beam
radiation therapy in treating patients with liver cancer that cannot be removed by surgery.
OBJECTIVES:
- To assess the feasibility and safety of radiotherapy (RT) in patients with
hepatocellular carcinoma. (Phase I)
- To assess the safety and efficacy of RT in these patients. (Phase II)
- To generate reproducible peptide patterns of the serum proteome or specific serum sub
proteomes in these patients.
- To assess changes in the proteome or sub proteome patterns after RT in these patients.
- To detect peptides that discriminate between before and after RT in these patients.
- To identify these discriminating peptides in these patients.
OUTLINE: This is a multicenter, phase I dose-escalation study followed by a phase II study.
Patients undergo radiotherapy (RT) once daily, five days a week, for 6 weeks.
Intensity-modulated, 3-dimensional conformal, or fractionated stereotactic RT may be used.
After completion of study therapy, patients in the phase I portion are followed for 1 year
and patients in the phase II portion are followed for 3 years.
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