Trial · NCT06820957
Testing a New Combination of Anti-cancer Drugs in Patients Newly Diagnosed With Ewing Sarcoma Who Have Cancer That Has Spread to Other Parts of the Body
NCT06820957, Phase 2, Phase 3, Terminated, Children's Oncology Group
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing a New Combination of Anti-cancer Drugs in Patients Newly Diagnosed With Ewing Sarcoma Who Have Cancer That Has Spread to Other Parts of the Body. Trials, record NCT06820957. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06820957
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing a New Combination of Anti-cancer Drugs in Patients Newly Diagnosed With Ewing Sarcoma Who Have Cancer That Has Spread to Other Parts of the Body
- NCT number
- NCT06820957
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 2 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
CIC-Rearranged Sarcoma, Metastatic Ewing Sarcoma, Metastatic High Grade Sarcoma, Metastatic Undifferentiated Round Cell Sarcoma, Metastatic Undifferentiated Sarcoma, Not Otherwise Specified, Round Cell Sarcoma With EWSR1-non-ETS Fusion, Sarcoma With BCOR Genetic Alterations
- Interventions
Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cyclophosphamide, Doxorubicin Hydrochloride, Echocardiography Test, Etoposide, Fludeoxyglucose F-18, Ifosfamide, Irinotecan Hydrochloride, Magnetic Resonance Imaging, Positron Emission Tomography, Questionnaire Administration, Radiation Therapy, Regorafenib, Surgical Procedure, Vincristine Sulfate
- First posted
- 2025-02-11
- Last updated
- 2026-10-05
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to event-free survival (EFS) post-Consolidation I (C1) | From randomization to progression or relapse, diagnosis of a second malignant neoplasm, death, or last patient contact, whichever occurs first, assessed up to 10 years | Analysis will be done by associating each patient's outcome with the individual's randomized treatment assignment. The associated statistical tests will be stratified according to grouping. |
| Secondary | Overall survival-C1 | From randomization to death or last patient contact, whichever occurs first, assessed up to 10 years | The stratified one-sided logrank test will be the primary statistical methodology for assessing the null statistical hypothesis. |
| Secondary | Incidence of adverse events | Up to 30 days after last dose of study treatment | Toxicity will be coded according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5. |
| Secondary | Feasibility of augmented dose radiotherapy (ADRT) as local control | Up to point of radiation therapy (RT) termination | The actual RT delivered will be compared with the treatment plan until the point of RT termination as assessed by central review. Will consider ADRT to be feasible to deliver if there is evidence that the patient-specific probability of feasibility-failure is less than 15%. |
| Secondary | Toxicity of ADRT as local control | Up to 30 days after ADRT is completed | Will be evaluated using CTCAE v 5. |
| Secondary | Validation of circulating tumor-derived deoxyribonucleic acid (ctDNA) levels greater than or equal to 5% at the time of diagnosis are associated with increased risk of EFS-event | At time of diagnosis | Will compare the risk for EFS-event from enrollment for groups of patients defined by percent ctDNA at diagnosis using a two-sided logrank test. |
| Secondary | Validation of ctDNA levels greater than or equal to 0.5% following one cycle of chemotherapy are associated with increased risk of EFS-event | Following one cycle of chemotherapy at induction (cycle length = 14 days) | Will compare the risk for EFS-event from enrollment for groups of patients defined by percent ctDNA at induction cycle 1 day 14 using a two-sided logrank test. |
| Other | EFS and response rate for patients with newly diagnosed eligible metastatic round cell sarcomas | At 1 and 2 years | The 95% confidence bounds will be calculated according to the complementary log-log transformation. Will report the 1-, 2- and 3-year estimate EFS probabilities as well as the confidence intervals. |
| Other | Change in fludeoxyglucose F-18 positron emission tomography imaging response of primary disease site and its association with EFS | At the end of 6 cycles of induction chemotherapy (cycle length = 14 days) | Will calculate the percent change in standardized uptake value (SUV). Will fit a Cox proportional hazards regression model for hazard of EFS-event with percent change in SUV included as an independent variable. Nonlinearity will be formally tested using a two degree of freedom Wald test of size 0.05 for the null hypothesis. The functional form of the relationship between hazard of EFS-event and percent change in SUV will be explored by plotting the model-predicted hazard on the logarithmic scale against percent change in SUV with 95% confidence bands. This plot will be examined for natural inflection points in the curve representing potentially informative categories of percent change in SUV. If the p-value for this test is not significant at the 0.05 level, will remove the nonlinear spline terms refitting the model with linear percent change in SUV, and will report the associated hazard ratio and 95% confidence interval. |
| Other | Histologic attributes of Ewing sarcoma and round cell sarcomas that mimic Ewing sarcoma | Up to 10 years | Qualitative characteristics will be quantified with the observed proportion in each category and the associated confidence interval. The sample mean, median, standard deviation, 25th percentile and 75th percentile will be used to characterize the distribution of the quantitative characteristics. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
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.
Grants1
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 |
|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source 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.
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/NCT06820957
GET https://conductscience.org/api/trials/v1/NCT06820957/registered