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NCT00980460 · ClinicalTrials.gov registry record · Phase 3
Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer
A Phase 3 study of PRETEXT I Hepatoblastoma and PRETEXT II Hepatoblastoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 236
- Enrollment target
- 20
- Study locations
NCT00980460: Active Phase 3 study of PRETEXT I Hepatoblastoma and PRETEXT II Hepatoblastoma, sponsored by National Cancer Institute (NCI).
NCT00980460 is a Phase 3 study of PRETEXT I Hepatoblastoma and PRETEXT II Hepatoblastoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 236 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00980460, a Phase 3 study of PRETEXT I Hepatoblastoma and PRETEXT II Hepatoblastoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 236 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial studies the side effects and how well risk-based therapy works in treating younger patients with newly diagnosed liver cancer. Surgery, chemotherapy drugs (cancer fighting medicines), and when necessary, liver transplant, are the main current treatments for hepatoblastoma. The stage of the cancer is one factor used to decide the best treatment. Treating patients according to the risk group they are in may help get rid of the cancer, keep it from coming back, and decrease the side effects of chemotherapy.
Primary Outcome
Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Fluorouracil
- DRUG Doxorubicin Hydrochloride
- DRUG Irinotecan Hydrochloride
- DRUG Dexrazoxane
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
- Cedars Sinai Medical Center - 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
Alabama
- Children's Hospital of Alabama - Birmingham
- University of Alabama at Birmingham Cancer Center - Birmingham
- USA Health Strada Patient Care Center - Mobile
Arizona
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Arkansas
- Arkansas Children's Hospital - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2009-09-14 |
| Est. Completion | 2026-03-19 |
| Phase | Phase 3 |
What the registry record for NCT00980460 still lists
NCT00980460 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 4 conditions, with PRETEXT I Hepatoblastoma appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT00980460 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00980460 about?
NCT00980460 is a clinical study titled "Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer". This phase III trial studies the side effects and how well risk-based therapy works in treating younger patients with newly diagnosed liver cancer. Surgery, chemotherapy drugs (cancer fighting medicines), and when necessary, liver transplant, are the main current treatments for hepatoblastoma. The s...
What is the current status of trial NCT00980460?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 236 participants. The study started on 2009-09-14. Estimated completion is 2026-03-19.
What conditions does trial NCT00980460 study?
This clinical trial studies the following conditions: PRETEXT I Hepatoblastoma, PRETEXT II Hepatoblastoma, PRETEXT III Hepatoblastoma, PRETEXT IV Hepatoblastoma.
What interventions are being tested in trial NCT00980460?
The interventions under investigation include: Cisplatin (DRUG), Fluorouracil (DRUG), Doxorubicin Hydrochloride (DRUG), Irinotecan Hydrochloride (DRUG), Dexrazoxane (DRUG).
Who is sponsoring clinical trial NCT00980460?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00980460 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00980460's enrollment target sits among peer trials
236 1295th of 2000 higher than 705 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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