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Randomized Controlled Trial of Transarterial Chemoembolization Versus Proton Beam Radiotherapy for the Treatment of Hepatocellular Carcinoma


N/A
18 Years
80 Years
Open (Enrolling)
Both
Carcinoma, Hepatocellular

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Trial Information

Randomized Controlled Trial of Transarterial Chemoembolization Versus Proton Beam Radiotherapy for the Treatment of Hepatocellular Carcinoma


Inclusion Criteria:



1. Patients are candidates to receive both proton beam and TACE

2. Patients with no evidence of metastasis or macrovascular invasion

3. Patients with tumor burden that meets San Francisco criteria

Exclusion Criteria:

1. Patients who are candidates for surgical resection

2. Patients with lesion < 2 cm

3. Patients who have contraindication to receive either TACE or proton

4. Patients with serum alpha fetoprotein > 500

5. Patients with metastasis or macrovascular invasion

6. Patients treated previously for HCC by any locoregional treatment

7. Patients with prior liver transplant

8. Patients with Child class C

9. Patients with MELD score of > 25

10. Patients with other comorbid diseases that may impact survival

11. Patients with ongoing alcohol intake

12. Patients with active sepsis

13. Patients with gastrointestinal bleeding within a week

14. Patients unwilling to sign informed consent form

15. Patients with history of noncompliance

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

lifetime

Safety Issue:

No

Principal Investigator

Zeid Kayali, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Loma Linda University Medical Center

Authority:

United States: Institutional Review Board

Study ID:

58348

NCT ID:

NCT00857805

Start Date:

January 2009

Completion Date:

January 2013

Related Keywords:

  • Carcinoma, Hepatocellular
  • Transarterial chemoembolization
  • Carcinoma, Hepatocellular
  • Proton Beam Radiotherapy
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

Loma Linda University Medical CenterLoma Linda, California  92354