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Phase I Study Evaluating the Treatment of Patients With Hepatocellular Carcinoma (HCC) With Carbon Ion Radiotherapy


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

Phase I Study Evaluating the Treatment of Patients With Hepatocellular Carcinoma (HCC) With Carbon Ion Radiotherapy


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

Determination the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of carbon ion radiotherapy

Outcome Time Frame:

3 months

Safety Issue:

Yes

Authority:

Germany: Federal Office for Radiation Protection

Study ID:

PROMETHEUS-01

NCT ID:

NCT01167374

Start Date:

August 2011

Completion Date:

January 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • HCC
  • Carcinoma
  • Carcinoma, Hepatocellular

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