Clinical trial · Interventional
Combination Chemotherapy With or Without Amifostine in Treating Young Patients With Liver Cancer
Intergroup Protocol for Treatment of Children With Hepatoblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. It is not yet known which chemotherapy regimen is most effective for children and young adults with liver cancer. This randomized phase III trial is studying giving combination chemotherapy together with amifostine to see how well it works compared to combination chemotherapy alone in treating patients with liver cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Hepatoblastoma | Childhood Hepatoblastoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Childhood Liver Cancer | Childhood Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Childhood Liver Cancer | Childhood Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amifostine trihydrate | Drug | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm I (cisplatin, vincristine sulfate, fluorouracil)
- description
- Patients receive therapeutic conventional surgery (tumor resection). Patients receive cisplatin IV over 4 hours on day 1, vincristine sulfate IV on days 3, 10, and 17, and fluorouracil on day 3.
- interventionNames
- Procedure: therapeutic conventional surgery
- Drug: cisplatin
- Drug: vincristine sulfate
- Drug: fluorouracil
- type
- EXPERIMENTAL
- label
- Arm II (cisplatin, vincristine, fluorouracil, amifostine)
- description
- Patients receive therapeutic conventional surgery (tumor resection). Patients receive treatment as in arm I with the addition of amifostine trihydrate IV over 15 minutes prior to cisplatin on day 1.
- interventionNames
- Procedure: therapeutic conventional surgery
- Drug: cisplatin
- Drug: vincristine sulfate
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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 resectionReferences
Publications (0)
Data not yet available