Trial · NCT03017326
Paediatric Hepatic International Tumour Trial
NCT03017326, Phase 3, Active not recruiting, University of Birmingham
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Paediatric Hepatic International Tumour Trial. Trials, record NCT03017326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03017326
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Paediatric Hepatic International Tumour Trial
- NCT number
- NCT03017326
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 450 participants, estimated
- Lead sponsor
- University of Birmingham
- Conditions
- Hepatoblastoma, Carcinoma, Hepatocellular
- Interventions
- Cisplatin, Doxorubicin, Carboplatin, 5Fluorouracil, Vincristine, Etoposide, Irinotecan, Gemcitabine, Oxaliplatin, Sorafenib
- First posted
- 2017-01-11
- Last updated
- 2026-05-13
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free survival (EFS) | From date of randomisation (or registration into the trial for non-randomised patients), until date of first failure event, assessed up to 6 years. | Event-free survival (EFS) is defined as the time from randomisation (or registration into the trial for non-randomised patients) to first failure event. Patients who have not had an event will be censored at their last follow-up date. Failure events are: * progression of existing disease or occurrence of disease at new sites, * death from any cause prior to disease progression, * diagnosis of a second malignant neoplasm. |
| Primary | Response in HCC is defined as complete (CR) or partial (PR) response according to RECIST version 1.1 criteria | From date of screening assessment until date of first response assessment, up to 63 days in Group F | Response in HCC is defined as complete (CR) or partial (PR) response according to RECIST version 1.1 criteria. The assessment will be performed after 3 cycles of PLADO, or 4 cycles of PLADO+S/GEMOX+S in Group F. Patients who are not assessable for response - e.g. because of early stopping of treatment or death - will be assumed to be non-responders. |
| Secondary | Failure-free survival (FFS) | From date of randomisation (or registration into the trial for non-randomised patients) until date of first failure event, or date of last follow up assessment, assessed up to 6 years. | Failure-free survival (FFS) is defined as the time from randomisation (or registration into the trial for non-randomised patients) to first failure event. Patients who have not had an event will be censored at their last follow-up date. Failure events are: * progression of existing disease or occurrence of disease at new sites, * death from any cause prior to disease progression, * diagnosis of a second malignant neoplasm. failure to go to resection. |
| Secondary | Overall survival (OS) | From date of randomisation (or registration for non-randomised patients) until date of death from any cause, or date of last follow up assessment, assessed up to 6 years. | Overall survival (OS) is defined as the time from randomisation (or registration for non-randomised patients) to death from any cause. Patients who have not died will be censored at their last follow-up date. |
| Secondary | Toxicity categorized and graded using Common Terminology Criteria for Adverse Events (CTCAE) | From date of start of randomised treatment until date 30 days after last treatment. | Toxicity will be recorded in relation to each cycle of randomised treatment and will be categorized and graded using Common Terminology Criteria for Adverse Events (CTCAE) |
| Secondary | Chemotherapy-related cardiac, nephro- and oto-toxicity using Common Terminology Criteria for Adverse Events (CTCAE) | From date of start of randomised treatment until date 30 days after last treatment. | Chemotherapy-related cardiac, nephro- and oto-toxicity will be recorded in relation to each cycle of treatment and will be categorized and graded using Common Terminology Criteria for Adverse Events (CTCAE) |
| Secondary | Hearing loss according to the SIOP Boston Scale | From date of registration until date of last follow up assessment, or date of death, assessed up to 6 years. | Hearing loss will be measured according to the SIOP Boston Scale for oto-toxicity. The assessment will be performed at end of treatment (EOT) and follow up |
| Secondary | Best Response | From date of first treatment until the date of last treatment, or until the date of first documented progression or date of death, assessed up to 6 months. | Best Response is defined as CR or PR and is based on radiological response (RECIST v1.1) and Alpha Fetoprotein (AFP) decline. Best Response will be measured throughout treatment period. Patients who are not assessable for response - e.g. because of early stopping of treatment or death - will be assumed to be non-responders. |
| Secondary | Surgical resectability defined as complete resection, partial resection or transplant | From date of registration until date of last follow up assessment, or date of death, assessed up to 6 years. | Surgical resectability is defined as complete resection, partial resection or transplant |
| Secondary | Adherence to surgical guidelines | From date of registration until date of last follow up assessment, or date of death, assessed up to 6 years. | Adherence to surgical guidelines is defined as the local clinician's surgical decision to resect or not compared to the current SIOPEL surgical guidelines. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT03017326
GET https://conductscience.org/api/trials/v1/NCT03017326/registered