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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00149565 |
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Date of registration:
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07/09/2005 |
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Primary sponsor: |
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Public title:
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Phase ? Randomized Trial in Postoperative Hepatocellular Carcinoma
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Scientific title:
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Hepatocellular Carcinoma Postoperative Adjuvant Therapy Disease Committee of Taiwan Cooperative Oncology Group |
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Date of first enrolment:
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October 1997 |
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Target sample size:
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268 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00149565 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Li-Tzong Chen, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hepatocellular Carcinoma Postoperative Adjuvant Therapy Disease Committee of TCOG |
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Name:
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Pei-Jer Chen, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hepatocellular Carcinoma Postoperative Adjuvant Therapy Disease Committee of TCOG |
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Key inclusion & exclusion criteria
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- Inclusion Criteria:
1. Histologically proven hepatocellular carcinoma.
2. HCC underwent curative resection within 6 weeks before registration.
3. Grossly, the resection margin should be > 1 cm.
4. Patients must be younger than 70 year-old.
5. Patients must have a performance status of ECOG score < 2.
6. Patients must have adequate liver reservation and adequate hemogram.
7. Pugh-Child‘s Score < 7.
8. The serum total bilirubin level are < 2 mg/dl.
9. The prothrombin times are < 3 sec above normal control.
10. The platelet are > 10 x 104 / mm3.
11. The WBC are > 3,000 / mm3.
12. Patient must have serum creatinine < 1.5 mg/dl
13. Cardiac function with NYHA classification < Grade II
14. Known HBV or HCV status.
15. Signed informed consent.
- Exclusion Criteria:
1. Patients who have non-curative resection are not eligible.
2. Resected HCCs with histologically positive margins are not eligible.
3. HCCs with radiological evidence of portal vein thrombus are not eligible.
4. Patients with other systemic diseases which required concurrent usage of
glucocorticosteroid or immunosuppressant agent(s) are not eligible.
5. Patients with advanced second primary malignancy are not eligible.
6. Patients with pregnacy or breast-feeding are not eligible.
7. Patients with severe cardiopulmonary diseases are not eligible.
8. Patients with clinically significant psychiatric disorder are not eligible.
9. Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or
corticosteroids within 6 weeks of commencing the protocol are not eligible.
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatocellular Carcinoma
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Intervention(s)
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Drug: IFN-a2b
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Primary Outcome(s)
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134 patients for each of the two treatment arms are needed.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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