Spots Global Cancer Trial Database for Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

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Trial Identification

Brief Title: Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Official Title: External Beam Radiotherapy for Unresectable Hepatocellular Carcinoma. A Multicenter Phase I/II Trial.

Study ID: NCT00777894

Conditions

Liver Cancer

Interventions

3-dimensional conformal radiation therapy

intensity-modulated radiation therapy

stereotactic body radiation therapy

Study Description

Brief Summary: 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.

Detailed Description: 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.