Carbon Ion Radiotherapy for Hepatocellular Carcinoma

Not Applicable

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Radiation: Carbon Ion Radiotherapy

• Registration Number: NCT01167374
• Lead Sponsor: University Hospital Heidelberg

Brief Summary

Treatment options for patients with advanced hepatocellular carcinoma (HCC) are often limited. In most cases, they are not amenable to local therapies including surgery or radiofrequency ablation. The multi-kinase inhibitor sorafenib has shown to increase overall survival in this patient group for about 3 months.

Radiation therapy is a treatment alternative, however, high local doses are required for long-term local control. However, due to the relatively low radiation tolerance of liver normal tissue, even using stereotactic techniques, delivery of sufficient doses for successful local tumor control has not be achieved to date.

Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 2 and 3 depending on the HCC cell line as well as the endpoint analyzed.

Japanese Data on the evaluation of carbon ion radiation therapy showed promising results for patients with HCC.

In the current Phase I-PROMETHEUS-01-Study, carbon ion radiotherapy will be evaluated for patients with advanced HCC. The study will be performed as a dose-escalation study evaluating the optimal carbon ion dose with respect to toxicity and tumor control.

Primary endpoint is toxicity, secondary endpoint is progression-free survival and response.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-20
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-22
• Study Start: 2011-08
• Primary Completion: 2022-08
• Study Completion: 2022-08
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• histologically confirmed HCC or diagnosis of HCC according to AASLD-guidelines
• macroscopic tumor
• liver-confined disease without extrahepatic disease as diagnosed by CT, MRT, ultrasound and bone scan
• minimal distance of tumor edge to the intestines of 1cm
• age ≥ 18 years of age
• Karnofsky Performance Score ³60
• For women with childbearing potential, (and men) adequate contraception.
• Ability of subject to understand character and individual consequences of the clinical trial
• Written informed consent (must be available before enrolment in the trial)

Exclusion Criteria

• refusal of the patients to take part in the study
• previous radiotherapy of the hepatobiliary system
• margin of < 1cm between tumor edge and intestines
• Patients who have not yet recovered from acute toxicities of prior therapies
• Known carcinoma < 2 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
• Pregnant or lactating women
• Participation in another clinical study or observation period of competing trials, respectively

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carbon Ion Radiotherapy	Carbon Ion Radiotherapy	Increasing Dose of Carbon Ion Radiotherapy 4 x 10 Gy E to 4 x 14 Gy E

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD)	3 months	Determination the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of carbon ion radiotherapy

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	Follow-up until progression up to 12 months

Trial Locations

Locations (1)

University Hospital of Heidelberg, Radiation Oncology; 🇩🇪 Heidelberg, Germany