Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma
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|ClinicalTrials.gov Identifier: NCT00077389|
Recruitment Status : Unknown
Verified December 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : February 12, 2004
Last Update Posted : June 24, 2014
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well neoadjuvant chemotherapy works in treating young patients who are undergoing surgical resection for high-risk hepatoblastoma.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Drug: carboplatin Drug: cisplatin Drug: doxorubicin hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||57 participants|
|Masking:||None (Open Label)|
|Official Title:||Intensified Pre-Operative Chemotherapy And Radical Surgery For High Risk Hepatoblastoma|
|Study Start Date :||January 2004|
- Rate of complete remission after completion of study therapy
- Complete resection rate
- Response rate to preoperative chemotherapy
- Rate of grade 2 cardiac and renal, grade 3 otological, and grade 4 nonhematological toxicity as assessed during and after completion of study therapy
- Overall survival
- Event-free survival
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): NCT00077389
|Study Chair:||Margaret Childs||Children's Cancer and Leukaemia Group|