Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-03 @ 12:08 PM
Study NCT ID:
NCT00777894
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
2008-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
Sponsor:
Swiss Cancer Institute
Organization:
Study Overview
Official Title:
External Beam Radiotherapy for Unresectable Hepatocellular Carcinoma. A Multicenter Phase I/II Trial.
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: