Radiation Dose Escalation Study for Advanced Liver Cancer

Fudan University

Status and phase: Completed; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Radiation: 3DCRT/IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT00848094

LCR-003

Details and patient eligibility

About

The purpose of this clinical study is to determine the maximum tolerated dose (MTD) of 3-dimensional conformal radiation therapy (3-DCRT)/intensity modulated radiation therapy (IMRT) for locally advanced hepatocellular carcinoma (HCC).

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed or clinically diagnosed HCC
• Surgically unsectable or medically inoperable diseases, or surgery declined by the patient
• Solitary intrahepatic lesion with diameter bigger than 5 cm, without extrahepatic and/or distant metastases
• Associated with cirrhosis of Child-Pugh A
• Karnofsky performance status (KPS) of ≥ 70
• Normal renal function and adequate bone marrow reservation
• Tolerate active breathing control (ABC)

Exclusion criteria

• Child-Pugh B or C liver cirrhosis score
• Previous radiotherapy to the liver
• Indistinct tumor boundary in CT/MRI image

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

arm 1

Other group

Description:

Arm I: tumor diameter more than 5 cm and less than 10 cm.

Treatment:

Radiation: 3DCRT/IMRT

Radiation: 3DCRT/IMRT

arm 2

Other group

Description:

Arm II: tumor diameter no less than 10 cm.

Treatment:

Radiation: 3DCRT/IMRT

Radiation: 3DCRT/IMRT