Clinical trial NCT00027768: Radioactive Iodine in Treating Patients Who Have Undergone Surgery for Liver Cancer
Official title: Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Liver Cancer
Keywords: localized resectable adult primary liver cancer
adult primary hepatocellular carcinoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 300
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: Radioactive iodine may be effective in reducing the rate of recurrence of liver cancer after surgery to remove the tumor. It is not yet known if radioactive iodine is more effective than no further treatment after surgery.

PURPOSE: Randomized phase III trial to determine the effectiveness of radioactive iodine in treating patients who have undergone surgery for liver cancer.

Detailed description: OBJECTIVES:

* Compare the effect of adjuvant hepatic intra-arterial iodine I 131 lipiodol vs observation in terms of rate of recurrence and overall survival of patients with curatively resected hepatocellular carcinoma.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Within 4-6 weeks after prior resection, patients receive adjuvant hepatic intra-arterial iodine I 131 lipiodol once.
* Arm II: After prior resection, patients undergo observation. Patients are followed monthly for 1 year and then every 3 months thereafter.

PROJECTED ACCRUAL: A minimum of 300 patients (150 per treatment arm) will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed primary hepatocellular carcinoma (HCC)
* Completely resected disease with clear margins
* No residual disease by postoperative CT scan
* No metastatic disease

PATIENT CHARACTERISTICS:

Age:

* 17 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* Not specified

Hematopoietic:

* WBC greater than 1,500/mm\^3
* Platelet count greater than 50,000/mm\^3

Hepatic:

* Bilirubin less than 2.92 mg/dL
* PT less than 4 seconds over control

Renal:

* Creatinine less than 2.26 mg/dL

Other:

* No contraindication to contrast or radioactive iodine
* No uncontrolled thyrotoxicosis
* No other prior or concurrent malignancy
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* See Disease Characteristics
* Recovered from prior surgery

Other

* No other prior treatment for HCC

Primary outcomes:
measure: Recurrence-free survival
Secondary outcomes:
measure: Overall survival
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre - Singapore
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: National Cancer Centre, Singapore
name: London L. Ooi Peng Jin, MD
role: STUDY_CHAIR
References: