Treatment of children with all stages of hepatoblastoma

eagle-i ID

Resource Type

Properties

1. Intervention

   Cisplatin

2. Intervention

   5-Fluorouracil

3. Intervention

   Vincristine

4. Intervention

   Surgery

5. Intervention

   Irinotecan

6. Additional Topic(s)

   Antineoplastic combined chemotherapy protocols

7. Additional Topic(s)

   Radiotherapy

8. Resource Description

   In this study, the risk level for the disease coming back after treatment is either very low, low, intermediate or high. Subjects are treated according to the risk group they are in. Other questions that researchers want to answer in this study are: Can a rating system called Pretreatment Extent of Disease (or PRETEXT) be used to decide if a tumor can be removed by surgery? Also, do different doctors give the same or different PRETEXT ratings when looking at the same patient’s tumor on a scan? Are there other factors that are present in children with hepatoblastoma that can be used to develop better treatments? For low-risk hepatoblastoma: Is it possible to give only 2 cycles of Cisplatin, 5-Fluorouracil and Vincristine, also called C5V (instead of the standard 4 cycles) in addition to taking out the tumor with surgery and still have good treatment success rates? For intermediate-risk hepatoblastoma: Can doxorubicin (chemotherapy) be given with C5V without causing too many side effects? For intermediate-risk and high-risk hepatoblastoma: Is it possible for subjects to be referred by their doctor to a center with experts in liver transplant surgery by the end of 2 cycles of chemotherapy? And is it then possible for these subjects to have their liver transplant done at the end of 4 cycles of chemotherapy? For high-risk hepatoblastoma: Are vincristine and irinotecan (types of chemotherapy) useful chemotherapy drugs for treating high-risk hepatoblastoma?

9. Contact

   Berenberg, Jeffrey

10. PI

    Wilkinson, Robert, M.D.

11. Topic

    hepatoblastoma

12. Study Population

    Persons 21 years or younger with any stage of newly diagnosed hepatoblastoma. Subjects previously treated with any kind of chemotherapy or other cancer therapy are not eligible for this study.

13. Funded by

    Children's Oncology Group

14. Phase

    Phase 3 clinical trial

15. Performed by

    Clinical Protocol & Data Management Shared Resource