Carbon Ion Radiotherapy for Hepatocellular Carcinoma (PROMETHEUS-01)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University Hospital Heidelberg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01167374
First received: July 20, 2010
Last updated: August 3, 2011
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Radiation: Carbon Ion Radiotherapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study Evaluating the Treatment of Patients With Hepatocellular Carcinoma (HCC) With Carbon Ion Radiotherapy

Resource links provided by NLM:


Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Determination the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of carbon ion radiotherapy


Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: Follow-up unti progression ] [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: August 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carbon Ion Radiotherapy
Increasing Dose of Carbon Ion Radiotherapy 4 x 10 Gy E to 4 x 14 Gy E
Radiation: Carbon Ion Radiotherapy
Increasing Dose of Carbon Ion Radiotherapy 4 x 10 Gy E to 4 x 14 Gy E

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167374

Contacts
Contact: Jürgen Debus, MD PhD +6221-56- ext 8201 juergen.debus@med.uni-heidelberg.de
Contact: Stephanie E Combs, MD +621-56- ext 8202 stephanie.combs@med.uni-heidelberg.de

Locations
Germany
University Hospital of Heidelberg, Radiation Oncology Recruiting
Heidelberg, Germany, 69120
Principal Investigator: Jürrgen Debus, MD PHD         
Sponsors and Collaborators
University Hospital Heidelberg
  More Information

No publications provided by University Hospital Heidelberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Dr. Jürgen Debus, University Hospital of Heidelberg, Radiation Oncology
ClinicalTrials.gov Identifier: NCT01167374     History of Changes
Other Study ID Numbers: PROMETHEUS-01
Study First Received: July 20, 2010
Last Updated: August 3, 2011
Health Authority: Germany: Federal Office for Radiation Protection

Keywords provided by University Hospital Heidelberg:
HCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 26, 2014