Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT00003994
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven hepatoblastoma
* Any stage allowed(stages II-IV closed to accrual as of 11-25-03)
* Stratum 1 (stage I):
* Pure fetal histology
* Complete surgical resection of tumor
* Stratum 2 (stages I or II) (stage II closed to accrual as of 11-25-03), meeting 1 of the following criteria:
* Complete resection of tumor with histology other than pure fetal
* Gross resection of tumor, including resected tumors with preoperative/intraoperative rupture
* Stratum 3 (stages III or IV) (stages III and IV closed to accrual as of 11-25-03), meeting 1 of the following criteria:
* Unresectable tumors
* Partial resection of tumor with measurable residual disease OR lymph node involvement
* Measurable metastatic disease to lungs or other organs
* No hepatocellular carcinoma
* Creatinine normal for age
* Glomerular filtration rate normal for age
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior biologic therapy
* No prior chemotherapy
* No prior endocrine therapy
* No prior radiotherapy
* See Disease Characteristics
* No prior therapy except tumor resection
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00003994
Study Brief:
Protocol Section:
NCT00003994