Trial · NCT02306161

Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma

NCT02306161, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2022-07-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma. Trials, record NCT02306161. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02306161

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Trial

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

Title: Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma
NCT number: NCT02306161
Status: Active not recruiting
Phases: Phase 3
Enrollment: 312 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Metastatic Ewing Sarcoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Neoplasm in the Bone Marrow, Metastatic Malignant Neoplasm in the Lung, Metastatic Peripheral Primitive Neuroectodermal Tumor of Bone, Peripheral Primitive Neuroectodermal Tumor of Soft Tissues
Interventions: Cyclophosphamide, Doxorubicin, Doxorubicin Hydrochloride, Etoposide, Etoposide Phosphate, External Beam Radiation Therapy, Ganitumab, Ifosfamide, Stereotactic Radiosurgery, Therapeutic Surgical Procedure, Vincristine, Vincristine Sulfate
First posted: 2014-12-03
Last updated: 2026-10-22
Results first posted: 2022-07-01

Source ClinicalTrials.gov

Registered outcomes14

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

List	Outcome	Time frame	Description
Primary	Event-free Survival	5 years after enrollment	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.
Secondary	Overall Survival	5 years after enrollment	Time from study enrollment to death or last patient contact.
Secondary	Frequency of Toxicity-events	Up to 202 days	The number of induction or consolidation reporting periods in which a CTC version 4 codeable grade 4 or greater non-hematological adverse event, grade 3 or greater left ventricular systolic dysfunction or the reporting period is terminated because of a CTC codeable event.
Other	Serum IGF Pathway Component and Tissue Protein, Deoxyribonucleic Acid (DNA), and Ribonucleic Acid Markers	Up to 10 years	In addition to the log rank test the modeling approach will be used for the primary study comparison. Linear trend in EFS-risk will be investigated by segregating the marker level according to quartiles. For bone marrow response rate analyses, Fisher's exact test will be used to compare the objective bone marrow response rate (complete response vs. incomplete response) at start of local control between patients with biomarker levels above and below the group median.
Other	Tumor Cell Surface IGF-1R Expression	Up to 307 days	Extent of tumor cell IGF-1R co-expression will also be reported. Change in tumor cell IGF-1R co-expression in patients treated with and without ganitumab will be reported descriptively.
Other	Germline Polymorphisms in EGFR	Up to 10 years	EFS will be compared between patients with and without the presence of the minor allele using the log rank test, both for the entire patient population and for patients randomized to ganitumab.
Other	EWS Translocation	Up to 10 years	The institutional result of EWS tumor testing will be categorized as translocation detected (yes v. no) and the type of translocation detected will also be recorded. The proportion of patients with a particular EWS translocation variant will be tabulated.
Other	Circulating Tumor DNA (ctDNA) Testing	Up to 202 days	Will report the proportion of patients that have a change in translocation result associated with ctDNA testing across time periods.
Other	Serial Genomic Profiling	Up to 307 days	Will be identified by flow cytometry. Profiles will be presented graphically, and samples obtained from different sites of tumor within the same individual will also be presented.
Other	Occurrence of Sinusoidal Obstructive Disease (SOS) Associated With the Addition of Ganitumab to VDC/IE	Up to 202 days	The number of induction and maintenance cycles received by patients randomized to the experimental therapy where SOS is observed. Only patients who receive all reporting period therapy or experience SOS will contribute to this outcome measure.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Event-free Survival	5 years after enrollment	Only eligible patients are considered in the calculation of this outcome measure.	percent probability of participants	NUMBER
SECONDARY	Overall Survival	5 years after enrollment	Only eligible patients are considered in the calculation of this outcome measure.	Percent Probability	NUMBER
SECONDARY	Frequency of Toxicity-events	Up to 202 days	Only eligible patients who received at least one dose of assigned protocol therapy are considered in the calculation of this outcome measure. Five hundred twenty-seven (527) reporting periods were contributed by patients enrolled on Regimen A; Five hundred seventy-six 576 reporting periods were contributed by patients enrolled on Regimen B.	Reporting Periods	NUMBER
OTHER_PRE_SPECIFIED	Serum IGF Pathway Component and Tissue Protein, Deoxyribonucleic Acid (DNA), and Ribonucleic Acid Markers	Up to 10 years
OTHER_PRE_SPECIFIED	Tumor Cell Surface IGF-1R Expression	Up to 307 days
OTHER_PRE_SPECIFIED	Germline Polymorphisms in EGFR	Up to 10 years
OTHER_PRE_SPECIFIED	EWS Translocation	Up to 10 years
OTHER_PRE_SPECIFIED	Circulating Tumor DNA (ctDNA) Testing	Up to 202 days
OTHER_PRE_SPECIFIED	Serial Genomic Profiling	Up to 307 days
OTHER_PRE_SPECIFIED	Occurrence of Sinusoidal Obstructive Disease (SOS) Associated With the Addition of Ganitumab to VDC/IE	Up to 202 days

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group6

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

Outcome	Group	Value	Spread	Units
Event-free Survival	Regimen A (VDC/IE)	30.88	95% Confidence Interval 22.50 to 39.63	percent probability of participants
Event-free Survival	Regimen B (VDC/IE + Ganitumab)	30.4	95% Confidence Interval 22.40 to 38.88	percent probability of participants
Overall Survival	Regimen A (VDC/IE)	44.93	95% Confidence Interval 33.61 to 55.60	Percent Probability
Overall Survival	Regimen B (VDC/IE + Ganitumab)	48.19	95% Confidence Interval 38.15 to 57.52	Percent Probability
Frequency of Toxicity-events	Regimen A (VDC/IE)	10		Reporting Periods
Frequency of Toxicity-events	Regimen B (VDC/IE + Ganitumab)	27		Reporting Periods

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Regimen A (VDC/IE)	157
Overall Study	STARTED	Regimen B (VDC/IE + Ganitumab)	155
Overall Study	COMPLETED	Regimen A (VDC/IE)	93
Overall Study	COMPLETED	Regimen B (VDC/IE + Ganitumab)	86
Overall Study	NOT COMPLETED	Regimen A (VDC/IE)	64
Overall Study	NOT COMPLETED	Regimen B (VDC/IE + Ganitumab)	69

Source ClinicalTrials.gov

Adverse events292

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	Events
other	Anemia	Blood and lymphatic system disorders	Regimen A (VDC/IE)	3	145	3
other	Anemia	Blood and lymphatic system disorders	Regimen B (VDC/IE + Ganitumab)	7	150	7
other	Febrile neutropenia	Blood and lymphatic system disorders	Regimen A (VDC/IE)	38	145	38
other	Febrile neutropenia	Blood and lymphatic system disorders	Regimen B (VDC/IE + Ganitumab)	50	150	50
other	Leukocytosis	Blood and lymphatic system disorders	Regimen A (VDC/IE)	1	145	1
other	Leukocytosis	Blood and lymphatic system disorders	Regimen B (VDC/IE + Ganitumab)	0	150	0
other	Sinus tachycardia	Cardiac disorders	Regimen A (VDC/IE)	0	145	0
other	Sinus tachycardia	Cardiac disorders	Regimen B (VDC/IE + Ganitumab)	1	150	1
other	Papilledema	Eye disorders	Regimen A (VDC/IE)	0	145	0
other	Papilledema	Eye disorders	Regimen B (VDC/IE + Ganitumab)	1	150	1

1 to 10 of 292Source ClinicalTrials.gov

See all 292 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Regimen A (VDC/IE)	61	145
Total, all-cause mortality	Regimen B (VDC/IE + Ganitumab)	67	150
Total, other adverse events	Regimen A (VDC/IE)	114	145
Total, other adverse events	Regimen B (VDC/IE + Ganitumab)	122	150
Total, serious adverse events	Regimen A (VDC/IE)	3	145
Total, serious adverse events	Regimen B (VDC/IE + Ganitumab)	45	150

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36669140	DERIVED	PubMed
42208702	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 comparisons2

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

Comparison	Source
Regimen A (VDC/IE) vs Regimen B (VDC/IE + Ganitumab): deaths from any cause	Trial comparisons
Regimen A (VDC/IE) vs Regimen B (VDC/IE + Ganitumab): serious adverse events	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/NCT02306161

GET https://conductscience.org/api/trials/v1/NCT02306161/events?page=2

API reference For AI assistants