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NCT03533582 · ClinicalTrials.gov registry record · Phase 3
Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery
A Phase 3 study of Hepatoblastoma and Fibrolamellar Carcinoma, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 3
- Development phase
- 537
- Enrollment target
- 20
- Study locations
NCT03533582: Active Phase 3 study of Hepatoblastoma and Fibrolamellar Carcinoma, sponsored by Children's Oncology Group.
NCT03533582 is a Phase 3 study of Hepatoblastoma and Fibrolamellar Carcinoma that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 537 participants, above the 220-participant average among 9 other Hepatoblastoma trials with a reported enrollment target (144% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03533582, a Phase 3 study of Hepatoblastoma and Fibrolamellar Carcinoma, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 537 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
EFS is defined as the time from randomization (or registration into the trial for non-randomized patients) to the first failure event where the failure events are defined as: progression of existing disease or occurrence of disease at new sites, death from any cause prior to disease progression, or diagnosis of a second malignant neoplasm. Patients who have not had an event will be censored at their last follow-up date. EFS for group A, group B1, group C, group D1, group D2 and E will be present
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- DRUG Cisplatin
- DRUG Doxorubicin
- DRUG Etoposide
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Sutter Medical Center Sacramento - Sacramento
- University of California Davis Comprehensive Cancer Center - Sacramento
- Rady Children's Hospital - San Diego - San Diego
- Naval Medical Center -San Diego - San Diego
- UCSF Medical Center-Mission Bay - San Francisco
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
Alabama
- Children's Hospital of Alabama - Birmingham
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 537 participants |
| Start Date | 2018-05-24 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
What the registry record for NCT03533582 still lists
NCT03533582 is an interventional study that assigns participants to a tested intervention. The registered 537 participants enrollment target is mid-sized for trials with a published cap, above the 220-participant average among 9 other Hepatoblastoma trials with a reported enrollment target (144% higher).
The record links to 5 conditions, with Hepatoblastoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT03533582 names 20 study sites across 5 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT03533582 about?
NCT03533582 is a clinical study titled "Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery". 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, vi...
What is the current status of trial NCT03533582?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 537 participants. The study started on 2018-05-24. Estimated completion is 2026-12-31.
What conditions does trial NCT03533582 study?
This clinical trial studies the following conditions: Hepatoblastoma, Fibrolamellar Carcinoma, Childhood Malignant Liver Neoplasm, Childhood Hepatocellular Carcinoma, Hepatocellular Malignant Neoplasm, Not Otherwise Specified.
What interventions are being tested in trial NCT03533582?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Cisplatin (DRUG), Doxorubicin (DRUG), Etoposide (DRUG).
Who is sponsoring clinical trial NCT03533582?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03533582 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03533582's enrollment target sits among peer trials
537 2nd of 9 the highest of 9 other Hepatoblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatoblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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