Efficacy of Radiation Therapy and Transarterial Chemoembolization (TACE) to Treat Hepatocellular Carcinoma (HCC)

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 31, 2011

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Hepatocellular Carcinoma
Interventions
OTHER

Radiation therapy

"A. Started 1 week after entry. B. Equipment: linear accelerator using 6-15 MV photons (external beam equipment). Computerized treatment planning system will be used to determine the radiation fields and 3D dose distribution.~C. Target volume: include only the portal vein tumor thrombus and 2 cm margin into the contiguous HCC. Respiratory movement will be tracked (4D-CT).~D. Dose:~i) Dose for fraction: 3 Gy, at 5 fractions/week ii) Total dose: 45 Gy E. Criteria for stopping RT i) Development of grade 3 or 4 hepatotoxicity or gastrointestinal complications, as defined by CTCAE ver 4.0. Restart of RT should be within 2 weeks after stopping RT."

OTHER

Transarterial chemoembolization

"A. Start at 2 weeks after completion of RT. B. TACE procedure: cisplatin 2 mg/kg infusion with 5-20 mL of lipiodol emulsion through the target artery of HCC. Gelfoam embolization will be used until to no tumor staining on re-angiography.~C. At an interval of 8 weeks twice, and then every 3 months until contraindications or complete response develop."

Sponsors
All Listed Sponsors
lead

Asan Medical Center

OTHER

NCT01432314 - Efficacy of Radiation Therapy and Transarterial Chemoembolization (TACE) to Treat Hepatocellular Carcinoma (HCC) | Biotech Hunter | Biotech Hunter