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Sho-Saiko-To Following Removal of Liver Cancer By Embolization in Treating Patients With Liver Cancer That Cannot Be Surgically Removed

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ClinicalTrials.gov Identifier: NCT00040898
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 18, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE July 8, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date January 18, 2013
Study Start Date  ICMJE January 2001
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00040898 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sho-Saiko-To Following Removal of Liver Cancer By Embolization in Treating Patients With Liver Cancer That Cannot Be Surgically Removed
Official Title  ICMJE Sho-Saiko-To After Ablation for Non-Resectable Hepatocellular Carcinoma (HCC): A Phase II Trial With Historical Control
Brief Summary

RATIONALE: The Chinese herbal medicine Sho-saiko-to contains ingredients that may slow the growth of tumor cells and stimulate a person's immune system to help kill tumor cells. This may be an effective treatment following hepatic artery embolization.

PURPOSE: Phase II trial to study the effectiveness of Sho-saiko-to following hepatic artery embolization in treating patients who have liver cancer.

Detailed Description

OBJECTIVES:

  • Compare the overall survival of patients with unresectable hepatocellular carcinoma treated with Sho-saiko-to after ablation therapy with embolization vs historical control patients.
  • Compare the liver function and alpha fetoprotein levels in patients treated with this drug vs historical control patients.
  • Compare the intervention-free survival in patients treated with this drug vs historical control patients.

OUTLINE: Beginning within 1 week after the first course of ablation therapy with embolization, patients receive oral Sho-saiko-to three times daily. Treatment with Sho-saiko-to continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 18-24 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Liver Cancer
Intervention  ICMJE Dietary Supplement: Sho-saiko-to
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • One of the following conditions:

    • Histologically confirmed unresectable hepatocellular carcinoma
    • Serum alpha-fetoprotein (AFP) level greater than 500 ng/mL with cirrhosis
    • Serum AFP level greater than 500 ng/mL with a liver mass and positive hepatitis B or C serology
  • Receiving ablation therapy with embolization
  • Extrahepatic disease allowed
  • No brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 50,000/mm^3
  • Hemoglobin greater than 8.0 g/dL

Hepatic:

  • See Disease Characteristics
  • Bilirubin less than 2.0 mg/dL
  • SGOT or SGPT less than 5 times upper limit of normal (ULN)
  • PT or INR less than 1.6 times ULN (if not receiving warfarin for anticoagulation)
  • Albumin greater than 2.5 g/dL

Renal:

  • Creatinine less than 1.8 mg/dL

Pulmonary:

  • DLCO at least 50% predicted OR
  • DLCO at least 70% predicted if total lung capacity less than 80% predicted
  • No significant lung disease

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No uncontrolled infection or pain
  • No other condition that would significantly impair cognitive functioning during the study
  • No overt psychosis, mental disability, or other incompetency that would preclude study
  • No other life-threatening illness for which the prognosis is poorer than for hepatocellular carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent interferon

Chemotherapy:

  • No prior chemotherapy within 4 weeks of initiating ablation therapy
  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy within 4 weeks of initiating ablation therapy
  • Concurrent radiotherapy allowed

Surgery:

  • See Disease Characteristics

Other:

  • See Disease Characteristics
  • No prior ablation therapy
  • No other concurrent Sho-saiko-to or any of its constituent plants
  • No other concurrent anticancer medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00040898
Other Study ID Numbers  ICMJE 01-002
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-01002
NCI-G02-2084
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Ronald DeMatteo, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP