Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma … (NCT03533582) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery
United States537 participantsStarted 2018-05-24
Plain-language summary
This partially randomized phase II/III trial studies how well, in combination with surgery, cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or hepatocellular carcinoma. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy may kill more tumor cells than one type of chemotherapy alone.
Who can participate
Age range30 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients in Group F must have a body surface area (BSA) \>= 0.6 m\^2
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
* Patients must be newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma, except as noted below; patients with a diagnosis of hepatocellular neoplasm, not otherwise specified, should be classified and treated per hepatoblastoma treatment arms; note that rapid central pathology review is required in some cases; please note: all patients with histology as assessed by the institutional pathologist consistent with pure small cell undifferentiated (SCU) HB will be required to have testing for INI1/SMARCB1 by immunohistochemistry (IHC) according to the practices at the institution
* Patients with histology consistent with pure SCU must have positive INI1/SMARCB1 staining
* For all Group A patients, WDF status as determined by rapid review will be used to further stratify patients to Group A1 or A2
* For Groups B, C and D, rapid review is required if patients are either \>= 8 years of age or have an alphafetoprotein (AFP) =\< 100 at dia…
What they're measuring
1
Event-free survival (EFS)
Timeframe: 3 years
2
Percentage of Group B2 participants with resectable tumors