Trial · NCT01946529

Therapeutic Trial for Patients With Ewing Sarcoma Family of Tumor and Desmoplastic Small Round Cell Tumors

NCT01946529, Phase 2, Completed, St. Jude Children's Research Hospital; results first posted 2016-10-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Therapeutic Trial for Patients With Ewing Sarcoma Family of Tumor and Desmoplastic Small Round Cell Tumors. Trials, record NCT01946529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01946529

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Trial

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

Title: Therapeutic Trial for Patients With Ewing Sarcoma Family of Tumor and Desmoplastic Small Round Cell Tumors
NCT number: NCT01946529
Status: Completed
Phases: Phase 2
Enrollment: 24 participants, actual
Lead sponsor: St. Jude Children's Research Hospital
Conditions: Desmoplastic Small Round Cell Tumor, Ewing Sarcoma of Bone or Soft Tissue, Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Interventions: vincristine, doxorubicin, cyclophosphamide, ifosfamide, etoposide, temozolomide, temsirolimus, bevacizumab, sorafenib, surgery, radiation
First posted: 2013-09-19
Last updated: 2026-08-21
Results first posted: 2016-10-19
Limitations and caveats: Interim analysis to evaluate efficacy of the therapy determined that the window therapy did not meet the anticipated response, and trial accrual was stopped. Some patients continue on therapy.

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Response to Window Therapy (2 Courses) for Group B (High-risk) - ESFT Participants	at 6 weeks after start of therapy (after 2 initial courses)	Response rate will be defined as the proportion of patients who achieved complete response or partial response (CR+PR) using the World Health Organization (WHO) criteria evaluated after two initial courses of temsirolimus, temozolomide and irinotecan in previously untreated patients with high risk Ewing Sarcoma Family of Tumor (ESFT). Participants who are treated in Group B with Desmoplastic Small Round Cell Tumor (DSRCT) or those who do not receive window therapy will not be included in this analysis.
Secondary	Overall Survival	Maximum of 11 years after the start of therapy	Overall survival (OS) is defined as the time interval from the date on study to the date of death or the date of last follow-up. OS will be estimated using the method of Kaplan-Meier for group A and B participants, respectively.
Secondary	Progression-free Survival	Maximum of 11 years after the start of therapy	Progression free survival (PFS) is defined as the time interval from the date on study to the date of disease progression or death or the date if last follow-up. PFS will be estimated using the method of Kaplan-Meier for group A and B participants, respectively.
Secondary	Time to Progression	Maximum of 11 years after the start of therapy	Median time to progression of group B patients will be estimated from the Kaplan-Meier curve.
Secondary	Local Failure Rate	Maximum of 11 years after the start of therapy	Loco-regional failure is defined as the time interval from date of start of local therapy to date of loco-regional failure. Distant failure or death prior to loco-regional failure will be considered competing events in the analyses. The cumulative incidence of loco-regional failure will be estimated using methods described in Kalbfleisch and Prentice.

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	Response to Window Therapy (2 Courses) for Group B (High-risk) - ESFT Participants	at 6 weeks after start of therapy (after 2 initial courses)	Of the 17 Group B participants with high-risk ESFT, 12 received window therapy and are considered evaluable for this outcome.	participants	NUMBER
SECONDARY	Overall Survival	Maximum of 11 years after the start of therapy
SECONDARY	Progression-free Survival	Maximum of 11 years after the start of therapy
SECONDARY	Time to Progression	Maximum of 11 years after the start of therapy
SECONDARY	Local Failure Rate	Maximum of 11 years after the start of therapy

Source ClinicalTrials.gov

Results by group3

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

Outcome	Group	Category	Value	Units
Response to Window Therapy (2 Courses) for Group B (High-risk) - ESFT Participants	Group B (High Risk) - ESFT	Partial Response (PR)	3	participants
Response to Window Therapy (2 Courses) for Group B (High-risk) - ESFT Participants	Group B (High Risk) - ESFT	Stable disease (no response) (NR)	8	participants
Response to Window Therapy (2 Courses) for Group B (High-risk) - ESFT Participants	Group B (High Risk) - ESFT	Progressive Disease (PD)	1	participants

Source ClinicalTrials.gov

Participant flow18

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

Period	Milestone	Group	Participants
End of Window Therapy (2 Courses)	STARTED	Group A (Standard Risk)	1
End of Window Therapy (2 Courses)	STARTED	Group B (High Risk) - ESFT	17
End of Window Therapy (2 Courses)	STARTED	Group B (High Risk) - DSRCT	6
End of Window Therapy (2 Courses)	COMPLETED	Group A (Standard Risk)	1
End of Window Therapy (2 Courses)	COMPLETED	Group B (High Risk) - ESFT	16
End of Window Therapy (2 Courses)	COMPLETED	Group B (High Risk) - DSRCT	6
End of Window Therapy (2 Courses)	NOT COMPLETED	Group A (Standard Risk)	0
End of Window Therapy (2 Courses)	NOT COMPLETED	Group B (High Risk) - ESFT	1
End of Window Therapy (2 Courses)	NOT COMPLETED	Group B (High Risk) - DSRCT	0
Completion of All Therapy	STARTED	Group A (Standard Risk)	1

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events268

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	Sinus tachycardia	Cardiac disorders	Group A (Standard Risk)	1	1	1
other	Sinus tachycardia	Cardiac disorders	Group B (High Risk) - ESFT	15	16	66
other	Sinus tachycardia	Cardiac disorders	Group B (High Risk) - DSRCT	6	6	21
other	Sinus tachycardia	Cardiac disorders	Group B (High Risk) - Total	21	22	87
other	Lymphocyte count decreased	Investigations	Group A (Standard Risk)	1	1	7
other	Lymphocyte count decreased	Investigations	Group B (High Risk) - ESFT	15	16	215
other	Lymphocyte count decreased	Investigations	Group B (High Risk) - DSRCT	6	6	48
other	Lymphocyte count decreased	Investigations	Group B (High Risk) - Total	21	22	263
other	Neutrophil count decreased	Investigations	Group A (Standard Risk)	1	1	6
other	Neutrophil count decreased	Investigations	Group B (High Risk) - ESFT	15	16	133

1 to 10 of 268Source ClinicalTrials.gov

See all 268 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group A (Standard Risk)
Total, all-cause mortality	Group B (High Risk) - ESFT
Total, all-cause mortality	Group B (High Risk) - DSRCT
Total, all-cause mortality	Group B (High Risk) - Total
Total, other adverse events	Group A (Standard Risk)	1	1
Total, other adverse events	Group B (High Risk) - ESFT	16	16
Total, other adverse events	Group B (High Risk) - DSRCT	6	6
Total, other adverse events	Group B (High Risk) - Total	22	22
Total, serious adverse events	Group A (Standard Risk)	0	1
Total, serious adverse events	Group B (High Risk) - ESFT	1	16

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

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.

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/NCT01946529

GET https://conductscience.org/api/trials/v1/NCT01946529/events?page=2

API reference For AI assistants