NCT00777894

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
RADIATION	3-dimensional conformal radiation therapy	Once daily RT sessions with 2 Gy, five days a week (on weekdays), will be performed. Phase I: Dose finding according to the following escalation table: Dose level Radiotherapy dose (1 x 2 Gy session/day, 5 sessions/week) 1. (3 patients) 27 x 2 Gy = 54 Gy 2. (3 patients) 29 x 2 Gy = 58 Gy, with optional field reduction after a dose of 54 Gy 3. (3 patients) 31 x 2 Gy = 62 Gy, with optional field reduction after a dose of 54 Gy 4. (5 patients) 33 x 2 Gy = 66 Gy, with optional field reduction after a dose of 54 Gy 5. (5 patients) 35 x 2 Gy = 70 Gy, with optional field reduction after a dose of 54 Gy Phase II: The dose for phase II will be recommended according to the MTD determined in phase I, if the MTD is 62 Gy or higher. If the MTD is 58 Gy or lower, the phase II part of the trial will not be performed.
RADIATION	intensity-modulated radiation therapy	Once daily RT sessions with 2 Gy, five days a week (on weekdays), will be performed. Phase I: Dose finding according to the following escalation table: Dose level Radiotherapy dose (1 x 2 Gy session/day, 5 sessions/week) 1. (3 patients) 27 x 2 Gy = 54 Gy 2. (3 patients) 29 x 2 Gy = 58 Gy, with optional field reduction after a dose of 54 Gy 3. (3 patients) 31 x 2 Gy = 62 Gy, with optional field reduction after a dose of 54 Gy 4. (5 patients) 33 x 2 Gy = 66 Gy, with optional field reduction after a dose of 54 Gy 5. (5 patients) 35 x 2 Gy = 70 Gy, with optional field reduction after a dose of 54 Gy Phase II: The dose for phase II will be recommended according to the MTD determined in phase I, if the MTD is 62 Gy or higher. If the MTD is 58 Gy or lower, the phase II part of the trial will not be performed.
RADIATION	stereotactic body radiation therapy	Once daily RT sessions with 2 Gy, five days a week (on weekdays), will be performed. Phase I: Dose finding according to the following escalation table: Dose level Radiotherapy dose (1 x 2 Gy session/day, 5 sessions/week) 1. (3 patients) 27 x 2 Gy = 54 Gy 2. (3 patients) 29 x 2 Gy = 58 Gy, with optional field reduction after a dose of 54 Gy 3. (3 patients) 31 x 2 Gy = 62 Gy, with optional field reduction after a dose of 54 Gy 4. (5 patients) 33 x 2 Gy = 66 Gy, with optional field reduction after a dose of 54 Gy 5. (5 patients) 35 x 2 Gy = 70 Gy, with optional field reduction after a dose of 54 Gy Phase II: The dose for phase II will be recommended according to the MTD determined in phase I, if the MTD is 62 Gy or higher. If the MTD is 58 Gy or lower, the phase II part of the trial will not be performed.

Timeline

• Start date: 2008-11-01
• Primary completion: 2014-01-01
• Completion: 2015-12-01
• First posted: 2008-10-22
• Last updated: 2019-05-15

Locations

6 sites across 2 countries: Netherlands, Switzerland