Trial · NCT00980460

Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer

NCT00980460, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2021-12-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer. Trials, record NCT00980460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00980460

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer
NCT number: NCT00980460
Status: Completed
Phases: Phase 3
Enrollment: 236 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: PRETEXT I Hepatoblastoma, PRETEXT II Hepatoblastoma, PRETEXT III Hepatoblastoma, PRETEXT IV Hepatoblastoma
Interventions: Cisplatin, Dexrazoxane, Doxorubicin Hydrochloride, Fluorouracil, Irinotecan Hydrochloride, Laboratory Biomarker Analysis, Liver Transplantation, Temsirolimus, Therapeutic Conventional Surgery, Vincristine Sulfate
First posted: 2009-09-21
Last updated: 2026-06-30
Results first posted: 2021-12-28

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Event-free Survival	Time from patient enrollment to progression, treatment failure, death from any cause, diagnosis of a second malignant neoplasm, or last follow-up, assessed up to 5 years	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.
Primary	Number of Cycles on Which Grade 3 or Higher Adverse Events Coded According to CTC AE Version 5 Were Observed	During protocol therapy up to 1 year after enrollment	All grade 3 or 4 or greater non-hematological toxicities. The frequency of each toxicity type will be quantified as the number of reporting periods on which the toxicity of the relevant grade is reported. This measure does not apply to patients enrolled in the VERY LOW RISK group.
Primary	Number of Deaths	During protocol therapy or within 30 days of the termination of protocol therapy up to 1 year after enrollment	Number of patients who experience on-protocol-therapy death possibly, probably or likely related to systemic chemotherapy. This outcome measure applies to INTERMEDIATE RISK patients only.
Primary	Disease Status at the End of 2 Courses of Therapy	First two cycles of therapy- up to 42 days after enrollment	RECIST v 1.1 and serum alphafetoprotein responses are evaluated separately. RECIST v 1.1 complete response (CR) is defined as disappearance of all target lesions and partial response (PR) is defined as reduction of at last 30% in the sum of the longest dimension of all target lesions (CR and PR measured by CT or MRI) between enrollment. Serum alphafetoprotein response is a decrease of at least 90% from the last serum alphafetoprotein measurement from the baseline prior to the start of chemotherapy to the end of cycle 2. This is calculated for HIGH RISK regimen W and HIGH RISK regimen H only.
Secondary	Feasibility of Referral for Liver Transplantation	3 cycles of therapy - up to 3 months after enrollment	A patient for whom referral is considered appropriate who receives a consultation after enrollment will be considered a success with respect to feasibility.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Event-free Survival	Time from patient enrollment to progression, treatment failure, death from any cause, diagnosis of a second malignant neoplasm, or last follow-up, assessed up to 5 years	Only eligible patients are considered in the calculation of this outcome measure.	Percent Probability	NUMBER
PRIMARY	Number of Cycles on Which Grade 3 or Higher Adverse Events Coded According to CTC AE Version 5 Were Observed	During protocol therapy up to 1 year after enrollment	All eligible patients except for patients in the very low-risk group. Regimen T includes 49 cycles, Regimen F includes 269 cycles, Regimen W includes 107 cycles and Regimen H includes 124 cycles.	Cycles	NUMBER
PRIMARY	Number of Deaths	During protocol therapy or within 30 days of the termination of protocol therapy up to 1 year after enrollment	Only eligible patients are considered in the calculation of this outcome measure.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Disease Status at the End of 2 Courses of Therapy	First two cycles of therapy- up to 42 days after enrollment	Thirty-two (32) patients were enrolled to Regiment W. Two were excluded from the analysis: (1)one was ineligible; and (2) one did not have an accurate report of initial AFP. Forty (40) patients were enrolled to Regiment H. Five were excluded from the analysis: (1)four were ineligible; and (2) one did not receive Temsirolimus.	participants	NUMBER
SECONDARY	Feasibility of Referral for Liver Transplantation	3 cycles of therapy - up to 3 months after enrollment	Only eligible patients with COG surgical stage III or IV disease and whose tumor is PRETEXT classified as PRETEXT 3-4 extensive multifocal; PRETEXT 3 +V; PRETEXT 3 +P; or PRETEXT 4 extensive multifocal are evaluated for feasibility of transplant referral.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group636

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Event-free Survival	Very Low-risk Group		100	95% Confidence Interval 100 to 100	Percent Probability
Event-free Survival	Low-risk Group (Regimen T)		87.21	95% Confidence Interval 73.67 to 94.06	Percent Probability
Event-free Survival	Intermediate-risk Group (Regimen F)		87.03	95% Confidence Interval 78.71 to 92.26	Percent Probability
Event-free Survival	High-risk Group (Regimen W)		43.61	95% Confidence Interval 25.79 to 60.16	Percent Probability
Event-free Survival	High-risk Group (Regimen H)		46.38	95% Confidence Interval 29.47 to 61.68	Percent Probability
Number of Cycles on Which Grade 3 or Higher Adverse Events Coded According to CTC AE Version 5 Were Observed	Low-risk Group (Regimen T)	Hearing impaired	1		Cycles
Number of Cycles on Which Grade 3 or Higher Adverse Events Coded According to CTC AE Version 5 Were Observed	Intermediate-risk Group (Regimen F)	Hearing impaired	20		Cycles
Number of Cycles on Which Grade 3 or Higher Adverse Events Coded According to CTC AE Version 5 Were Observed	High-risk Group (Regimen W)	Hearing impaired	4		Cycles
Number of Cycles on Which Grade 3 or Higher Adverse Events Coded According to CTC AE Version 5 Were Observed	High-risk Group (Regimen H)	Hearing impaired	4		Cycles
Number of Cycles on Which Grade 3 or Higher Adverse Events Coded According to CTC AE Version 5 Were Observed	Low-risk Group (Regimen T)	Diarrhea	4		Cycles

1 to 10 of 636Source ClinicalTrials.gov

See all 636 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Very Low-risk Group	8
Overall Study	STARTED	Low-risk Group (Regimen T)	51
Overall Study	STARTED	Intermediate-risk Group (Regimen F)	105
Overall Study	STARTED	High-risk Group (Regimen W)	32
Overall Study	STARTED	High-risk Group (Regimen H)	40
Overall Study	COMPLETED	Very Low-risk Group	8
Overall Study	COMPLETED	Low-risk Group (Regimen T)	47
Overall Study	COMPLETED	Intermediate-risk Group (Regimen F)	70
Overall Study	COMPLETED	High-risk Group (Regimen W)	14
Overall Study	COMPLETED	High-risk Group (Regimen H)	24

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events880

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal distension	Gastrointestinal disorders	Very Low-risk Group	0	8
other	Abdominal distension	Gastrointestinal disorders	Low-risk Group (Regimen T)	0	49
other	Abdominal distension	Gastrointestinal disorders	Intermediate-risk Group (Regimen F)	1	102
other	Abdominal distension	Gastrointestinal disorders	High-risk Group (Regimen W)	1	31
other	Abdominal distension	Gastrointestinal disorders	High-risk Group (Regimen H)	0	36
other	Abdominal infection	Infections and infestations	Very Low-risk Group	0	8
other	Abdominal infection	Infections and infestations	Low-risk Group (Regimen T)	0	49
other	Abdominal infection	Infections and infestations	Intermediate-risk Group (Regimen F)	1	102
other	Abdominal infection	Infections and infestations	High-risk Group (Regimen W)	0	31
other	Abdominal infection	Infections and infestations	High-risk Group (Regimen H)	0	36

1 to 10 of 880Source ClinicalTrials.gov

See all 880 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Very Low-risk Group	0	8
Total, all-cause mortality	Low-risk Group (Regimen T)	3	49
Total, all-cause mortality	Intermediate-risk Group (Regimen F)	7	102
Total, all-cause mortality	High-risk Group (Regimen W)	11	31
Total, all-cause mortality	High-risk Group (Regimen H)	13	36
Total, other adverse events	Very Low-risk Group	0	8
Total, other adverse events	Low-risk Group (Regimen T)	24	49
Total, other adverse events	Intermediate-risk Group (Regimen F)	91	102
Total, other adverse events	High-risk Group (Regimen W)	27	31
Total, other adverse events	High-risk Group (Regimen H)	32	36

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30975630	DERIVED	PubMed
34874751	DERIVED	PubMed
37073741	DERIVED	PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180886	COG NCTN Network Group Operations Center	Hawkins, Douglas S.	COG RESEARCH FOUNDATION, LLC	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013	NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Intermediate-risk Group (Regimen F) vs High-risk Group (Regimen H): Feasibility of Referral for Liver Transplantation

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00980460

GET https://conductscience.org/api/trials/v1/NCT00980460/results?page=2

API reference For AI assistants