Combined Radiotherapy and Sorafenib in Patients With Hepatoma

NCT01319942 | Unknown DMC

• 1 other identifier: RT-sorafenib
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to test the efficacy of combined radiotherapy and sorafenib in patients with locally advanced hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

Radiotherapy; Sorafenib; Treatment outcome

Outcome Measures

Primary Outcomes (1)

• Response rate

  1. Response rate at 1-month and 6-month after radiotherapy. 2. Toxicities profile of combinede treatment

  1-month and 6-month response rate

Secondary Outcomes (1)

• Time-to radiological progression interval

  2-years

Study Arms (1)

Unresectable hepatoma

Unresectable hepatoma, unsuitable for transarterial embolization or local failure after transarterial embolization

Other: Radiotherapy combined with sorafenib

Interventions

Radiotherapy combined with sorafenib OTHER

Radiotherapy: 46 Gy to 60 Gy prescribed to involved hepatic tumor Sorafenib: 2 tablet of sorafenib (200mg) twice daily (totally 800mg per day)

Also known as: Radiotherapy with sorafenib

Unresectable hepatoma

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

45 patients withunresectable hepatoma

You may qualify if:

• Patients with unresectable hepatoma with transarterial embolization (TAE) failure or who are not suitable for TAE.
• Age: 20 \~ 69 years.
• ECOG 0 or 1.
• Life expectancy of at least 12 weeks.
• Child-Pugh A or B (preferentially score ≦ 7).
• Cancer of the Liver Italian Program (CLIP) score ≦ 3.
• Pretreatment liver function test and renal function test:
• Total bilirubin \< 1.5 times the upper limit of normal (ULN)≦ 3.0(ULN)in patients treated by biliary drainage for obstructive jaundice.
• GOP/GPT ≦ 5 X of upper limit of normal range.
• Alkaline phosphatase ≦ 4X of upper limit of normal range.
• Prothrombin time/partial prothrombin time \< 1.5 X of ULN.
• Serum Creatinine ≦ 1.0 x ULN.
• Pretreatment blood count:
• Hemoglobulin ≧ 9 g/dl.
• Absolute neutrophil count ≧ 1500/mm3.

You may not qualify if:

• Child-Pugh C
• CLIP score ≧ 4
• Patients with evidence of extrahepatic or metastatic disease
• Patients with evidence of massive ascites
• Patients receiving previous irradiation to liver
• Patients with previous use of Thalidomide less than 6 months from entering of the study
• History of cardiac disease: congestive heart failure \>NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted)
• Active clinically serious infections ( \> grade 2 CTC version 2)
• Patients undergoing renal dialysis
• Patients with evidence or history of bleeding diathesis
• Prior treatment with EGFR TKIs or VEGFR TKIs
• Hypertension uncontrolled by medical therapy
• Symptomatic metastatic brain or meningeal tumors unless the patient is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. Also the patient must not be undergoing acute steroid therapy or taper.
• Chemotherapy or immunotherapy or other systemic anti-cancer therapy within 4 weeks (6 weeks for nitrosoureas, mitomycin and suramin)
• Major surgery within 4 weeks of start of study

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (2)

Chi-Mei Hospital

Tainan, Taiwan, 600, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib; Radiotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Therapeutics

Study Officials

• Shang-Wen Chen, MD

  Department of Radiation Oncology, China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shang-Wen Chen, MD

CONTACT

886-4-22052121; vincent1680616@yahoo.com.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: March 22, 2011
• Study Start: June 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2013
• Last Updated: March 22, 2011

Record last verified: 2011-03

Locations

TW (2)