Trial · NCT00554788

Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma

NCT00554788, Phase 3, Completed, Children's Oncology Group; results first posted 2019-06-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma. Trials, record NCT00554788. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00554788

On this page

Trial

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

Title: Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma
NCT number: NCT00554788
Status: Completed
Phases: Phase 3
Enrollment: 60 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Extraocular Retinoblastoma
Interventions: Autologous Bone Marrow Transplantation, Autologous Hematopoietic Stem Cell Transplantation, Carboplatin, Cisplatin, Cyclophosphamide, Etoposide, Filgrastim, In Vitro-Treated Peripheral Blood Stem Cell Transplantation, Radiation Therapy, Thiotepa, Vincristine Sulfate
First posted: 2007-11-07
Last updated: 2025-01-13
Results first posted: 2019-06-26

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Event-free Survival (EFS)	At 1 year	The probability of surviving patients who did not experience events at 1 year following enrollment. An event is defined as relapse, second malignancy, or death from any cause.
Secondary	Response Rate to the Induction Phase of the Regimen	12 weeks after participant received the first dose	This study used a modified version of the international criteria for neuroblastoma response. The response rate to the induction phase of the regimen and a corresponding 95% confidence interval will be calculated for all strata combined.
Secondary	Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Up to 30 days after completion of study treatment	Grade 3 and higher toxicities will be descriptively summarized.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Event-free Survival (EFS)	At 1 year	Ineligible patients were excluded from analysis	Probability	NUMBER
SECONDARY	Response Rate to the Induction Phase of the Regimen	12 weeks after participant received the first dose	Ineligible patients were excluded from analysis	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Up to 30 days after completion of study treatment	Three ineligible patients were excluded from this analysis. Two patients who did not receive therapy were also excluded from this analysis.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group166

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

Outcome	Group	Category	Value	Spread	Units
Event-free Survival (EFS)	Stage 2/3 Patients		88	95% Confidence Interval 60 to 97	Probability
Event-free Survival (EFS)	Stage 4a Patients		83	95% Confidence Interval 55 to 94	Probability
Event-free Survival (EFS)	Stage 4b Patients		28	95% Confidence Interval 10 to 49	Probability
Response Rate to the Induction Phase of the Regimen	All Eligible Patients		68	95% Confidence Interval 56 to 79	percentage of participants
Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Stage 2/3 Patients	Abdominal pain	0		percentage of participants
Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Stage 4a Patients	Abdominal pain	5.6		percentage of participants
Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Stage 4b Patients	Abdominal pain	0		percentage of participants
Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Stage 2/3 Patients	Acute kidney injury	0		percentage of participants
Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Stage 4a Patients	Acute kidney injury	5.6		percentage of participants
Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Stage 4b Patients	Acute kidney injury	0		percentage of participants

1 to 10 of 166Source ClinicalTrials.gov

See all 166 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Stage 2/3 Patients	21
Overall Study	STARTED	Stage 4a Patients	18
Overall Study	STARTED	Stage 4b Patients	21
Overall Study	COMPLETED	Stage 2/3 Patients	14
Overall Study	COMPLETED	Stage 4a Patients	12
Overall Study	COMPLETED	Stage 4b Patients	7
Overall Study	NOT COMPLETED	Stage 2/3 Patients	7
Overall Study	NOT COMPLETED	Stage 4a Patients	6
Overall Study	NOT COMPLETED	Stage 4b Patients	14

Source ClinicalTrials.gov

Adverse events171

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 pain	Gastrointestinal disorders	Stage 2/3 Patients	0	18
other	Abdominal pain	Gastrointestinal disorders	Stage 4a Patients	1	18
other	Abdominal pain	Gastrointestinal disorders	Stage 4b Patients	0	19
other	Acute kidney injury	Renal and urinary disorders	Stage 2/3 Patients	0	18
other	Acute kidney injury	Renal and urinary disorders	Stage 4a Patients	1	18
other	Acute kidney injury	Renal and urinary disorders	Stage 4b Patients	0	19
other	Alanine aminotransferase increased	Investigations	Stage 2/3 Patients	0	18
other	Alanine aminotransferase increased	Investigations	Stage 4a Patients	3	18
other	Alanine aminotransferase increased	Investigations	Stage 4b Patients	1	19
other	Anemia	Blood and lymphatic system disorders	Stage 2/3 Patients	0	18

1 to 10 of 171Source ClinicalTrials.gov

See all 171 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Stage 2/3 Patients	2	18
Total, all-cause mortality	Stage 4a Patients	5	18
Total, all-cause mortality	Stage 4b Patients	15	19
Total, other adverse events	Stage 2/3 Patients	13	18
Total, other adverse events	Stage 4a Patients	12	18
Total, other adverse events	Stage 4b Patients	10	19
Total, serious adverse events	Stage 2/3 Patients	1	18
Total, serious adverse events	Stage 4a Patients	2	18
Total, serious adverse events	Stage 4b Patients	0	19

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35820112	DERIVED

Source 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 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.

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/NCT00554788

GET https://conductscience.org/api/trials/v1/NCT00554788/results?page=2

API reference For AI assistants