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

Phase 1

Completed

• Conditions: Liver Cancer
• Interventions: Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy; Radiation: stereotactic body radiation therapy

• Registration Number: NCT00777894
• Lead Sponsor: Swiss Group for Clinical Cancer Research

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.

Study Timeline

• Study First Submitted: 2008-10-21
• Study First Submitted QC: 2008-10-21
• Study First Posted: 2008-10-22
• Study Start: 2008-11
• Primary Completion: 2014-01
• Study Completion: 2015-12
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiation: 3-dimensional conformal radiation therapy	stereotactic body radiation therapy	-
Radiation: 3-dimensional conformal radiation therapy	3-dimensional conformal radiation therapy	-
Radiation: 3-dimensional conformal radiation therapy	intensity-modulated radiation therapy	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (Phase I)	during RT or within 30 days after the last RT dose, is a DLT.
Best objective response of target liver lesions (TLLs)	according to RECIST criteria for up to 1 year after completion of study therapy (Phase II)

Secondary Outcome Measures

Name	Time	Method
Best objective response of TLLs according to RECIST criteria (Phase I)	according to RECIST criteria (Phase I)
Volumetric response of TLLs	at 5 months after completion of study therapy (Phase II)
Child-Pugh Score	at last study visit and at 1, 2, 3, and 5 months after completion of study therapy (Phase II)
Serum alpha-fetoprotein level (Phase II)	will be measured until progression, if AFP is ≥ 1.5 x ULN at baseline.
Adverse events according to NCI CTCAE v.3.0	during therapy and within 3 months after completion of study therapy (Phases I and II)
Time to progression of TLLs (Phase II)	calculated from registration until documented tumor progression of target liver lesions.
Duration of response of TLLs (Phase II)	the time from achieving an objective response (CR + PR) to a progression of target liver lesions according to RECIST or death.
Stable disease of TLLs (Phase II)	will be determined according to RECIST
Progression-free survival (Phase II)	calculated from registration until documented tumor progression or death, whichever occurs first.
Compensatory liver tissue hypertrophy at baseline and at 5 months after completion of study therapy (Phase II)	Increase in residual liver volume (= total liver - GTV) (ml) between registration and 5 months after RT will be calculated
Time to liver event (Phase II)	from registration until progressive liver disease.
Overall survival (Phase II)	calculated from registration until death

Trial Locations

Locations (6)

Maastro Lab at University of Maastricht; 🇳🇱 Maastricht, Netherlands

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni; 🇨🇭 Bellinzona, Switzerland

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland

Universitaetsspital-Basel; 🇨🇭 Basel, Switzerland

Inselspital Bern; 🇨🇭 Bern, Switzerland

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland