Combination Chemotherapy and Thalidomide in Treating Younger Patients Undergoing Surgery For Newly Diagnosed Liver Cancer
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|ClinicalTrials.gov Identifier: NCT00276705|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 13, 2006
Last Update Posted : September 17, 2013
RATIONALE: Drugs used in chemotherapy, such as cisplatin and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Thalidomide may stop the growth of liver cancer by blocking blood flow to the tumor. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Giving combination chemotherapy, thalidomide, and chemoembolization before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving thalidomide together with chemotherapy after surgery may kill any remaining tumor cells and prevent the tumor from coming back.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy and thalidomide together with chemoembolization works in treating younger patients undergoing surgery for newly diagnosed liver cancer.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: thalidomide Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Masking:||None (Open Label)|
|Official Title:||Hepatocellular Carcinoma Family of Tumours In Children / Adolescents and Young Adults|
|Study Start Date :||June 2005|
|Estimated Primary Completion Date :||April 2009|
- Event-free and overall survival following tumor resection
- Efficacy and tolerability following course 2 and 4 of pre-operative chemotherapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276705
|Study Chair:||Bruce Morland, MD||Birmingham Children's Hospital|