Trial · NCT02567435
Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma
NCT02567435, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2024-10-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma. Trials, record NCT02567435. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02567435
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma
- NCT number
- NCT02567435
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 325 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Alveolar Rhabdomyosarcoma, Botryoid-Type Embryonal Rhabdomyosarcoma, Embryonal Rhabdomyosarcoma, Rhabdomyosarcoma, Sclerosing Rhabdomyosarcoma, Spindle Cell Rhabdomyosarcoma
- Interventions
- Cyclophosphamide, Dactinomycin, Irinotecan Hydrochloride, Laboratory Biomarker Analysis, Questionnaire Administration, Radiation Therapy, Temsirolimus, Vincristine Sulfate, Vinorelbine
- First posted
- 2015-10-05
- Last updated
- 2026-10-01
- Results first posted
- 2024-10-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival (EFS) | Up to 3 years from study entry | The Kaplan-Meier method will used to estimate 3-year EFS between the randomized treatment groups (Regimen A (VAC/VI) vs. Regimen B (VAC/VI/Temsirolimus)) using the log-rank test. EFS event is defined as the time from study entry until first occurrence of progression, relapse, second malignancy, or death. |
| Secondary | Overall Survival (OS) | Up to 3 years from study entry | The Kaplan-Meier method will used to estimate 3-year OS between the randomized treatment groups (Regimen A (VAC/VI) vs. Regimen B (VAC/VI/Temsirolimus)) using the log-rank test. OS event is defined as the time from study entry until death. |
| Other | Frequency of Circulating Tumor DNA (ctDNA) at Diagnosis and Subsequent Time-points | Up to 10 years | Will determine the frequency with which of ctDNA is detected in patients with intermediate-risk (IR) rhabdomyosarcoma (RMS) at diagnosis and how these levels change over time with. In addition, the level of ctDNA as a percent of total cell-free DNA will be summarized by reporting the median and range. Since no prior data are available on the rate of positivity nor the change over time, the analysis will be purely descriptive. Changes over time will be plotted to visually determine and compare the trajectories of ctDNA during the early and late stages of therapy. |
| Other | Patient Outcome Based on Their Forkhead Box O1 Protein (FOXO1) Partner, by Evaluating PAX3 vs. PAX7 in All Patients Found to be FOXO1 Fusion Positive | Up to 10 years | |
| Other | Patient Outcome Based on Their [F18]-Fluorodeoxy-D-glucose-positron Emission Tomography (FDG-positron Emission Tomography [PET]) Response | At week 9 | Assessed by Deauville Criteria (5-point). |
| Other | Patient Outcomes Based on (Vincristine, Dactinomycin, and Cyclophosphamide [VAC]/Vincristine and Irinotecan [VI] With or Without Temsirolimus) Who Have Received Maintenance Therapy on ARST1431 to Those Who Received VAC/VI on ARST0531 | Up to 10 years | The two-sample log-rank test will be performed. |
Source ClinicalTrials.gov
Outcomes6
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) | Up to 3 years from study entry | As pre-specified in the protocol, patients randomized to Regimen A (VAC/VI) and Regimen B (VAC/VI/Temsirolimus) were included in this analysis. The data was analyzed with revised intention-to-treat approach. Following patients were excluded 4 ineligible patients, 11 feasibility patients and 13 inevaluable patients (due to FOXO1 results or who did not receive maintenance therapy due to an amendment added during the study) . | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Up to 3 years from study entry | As pre-specified in the protocol, patients randomized to Regimen A (VAC/VI) and Regimen B (VAC/VI/Temsirolimus) were included in this analysis. The data was analyzed with revised intention-to-treat approach. Following patients were excluded 4 ineligible patients, 11 feasibility patients and 13 inevaluable patients (due to FOXO1 results or who did not receive maintenance therapy due to an amendment added during the study) . | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Frequency of Circulating Tumor DNA (ctDNA) at Diagnosis and Subsequent Time-points | Up to 10 years | |||
| OTHER_PRE_SPECIFIED | Patient Outcome Based on Their Forkhead Box O1 Protein (FOXO1) Partner, by Evaluating PAX3 vs. PAX7 in All Patients Found to be FOXO1 Fusion Positive | Up to 10 years | |||
| OTHER_PRE_SPECIFIED | Patient Outcome Based on Their [F18]-Fluorodeoxy-D-glucose-positron Emission Tomography (FDG-positron Emission Tomography [PET]) Response | At week 9 | |||
| OTHER_PRE_SPECIFIED | Patient Outcomes Based on (Vincristine, Dactinomycin, and Cyclophosphamide [VAC]/Vincristine and Irinotecan [VI] With or Without Temsirolimus) Who Have Received Maintenance Therapy on ARST1431 to Those Who Received VAC/VI on ARST0531 | Up to 10 years |
Source ClinicalTrials.gov
Results by group4
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) | Regimen A (VAC/VI) | 64.80 | 95% Confidence Interval 55.5 to 74.1 | Percentage of participants | |
| Event-free Survival (EFS) | Regimen B (VAC/VI/Temsirolimus) | 66.80 | 95% Confidence Interval 57.5 to 76.2 | Percentage of participants | |
| Overall Survival (OS) | Regimen A (VAC/VI) | 78.70 | 95% Confidence Interval 70.9 to 86.4 | Percentage of participants | |
| Overall Survival (OS) | Regimen B (VAC/VI/Temsirolimus) | 77.80 | 95% Confidence Interval 69.7 to 85.9 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regimen A (VAC/VI) | 156 | |
| Overall Study | STARTED | Regimen B (VAC/VI/Temsirolimus) | 156 | |
| Overall Study | STARTED | Regimen C (FOXO1 Fusion Negative, VAC/VA) | 3 | |
| Overall Study | STARTED | Feasibility (VAC/VI/Temsirolimus) | 10 | |
| Overall Study | COMPLETED | Regimen A (VAC/VI) | 150 | |
| Overall Study | COMPLETED | Regimen B (VAC/VI/Temsirolimus) | 147 | |
| Overall Study | COMPLETED | Regimen C (FOXO1 Fusion Negative, VAC/VA) | 3 | |
| Overall Study | COMPLETED | Feasibility (VAC/VI/Temsirolimus) | 9 | |
| Overall Study | NOT COMPLETED | Regimen A (VAC/VI) | 6 | |
| Overall Study | NOT COMPLETED | Regimen B (VAC/VI/Temsirolimus) | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,412
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 | Abdominal distension | Gastrointestinal disorders | Regimen A (VAC/VI) | 3 | 155 | 3 |
| other | Abdominal distension | Gastrointestinal disorders | Regimen B (VAC/VI/Temsirolimus) | 2 | 153 | 3 |
| other | Abdominal distension | Gastrointestinal disorders | Regimen C (FOXO1 Fusion Negative, VAC/VA) | 0 | 3 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Feasibility (VAC/VI/Temsirolimus) | 1 | 10 | 1 |
| other | Abdominal infection | Infections and infestations | Regimen A (VAC/VI) | 1 | 155 | 2 |
| other | Abdominal infection | Infections and infestations | Regimen B (VAC/VI/Temsirolimus) | 1 | 153 | 2 |
| other | Abdominal infection | Infections and infestations | Regimen C (FOXO1 Fusion Negative, VAC/VA) | 0 | 3 | 0 |
| other | Abdominal infection | Infections and infestations | Feasibility (VAC/VI/Temsirolimus) | 0 | 10 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Regimen A (VAC/VI) | 15 | 155 | 23 |
| other | Abdominal pain | Gastrointestinal disorders | Regimen B (VAC/VI/Temsirolimus) | 29 | 153 | 36 |
1 to 10 of 1,412Source ClinicalTrials.gov
See all 1,412 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regimen A (VAC/VI) | 33 | 155 |
| Total, all-cause mortality | Regimen B (VAC/VI/Temsirolimus) | 33 | 153 |
| Total, all-cause mortality | Regimen C (FOXO1 Fusion Negative, VAC/VA) | 0 | 3 |
| Total, all-cause mortality | Feasibility (VAC/VI/Temsirolimus) | 4 | 10 |
| Total, other adverse events | Regimen A (VAC/VI) | 139 | 155 |
| Total, other adverse events | Regimen B (VAC/VI/Temsirolimus) | 141 | 153 |
| Total, other adverse events | Regimen C (FOXO1 Fusion Negative, VAC/VA) | 1 | 3 |
| Total, other adverse events | Feasibility (VAC/VI/Temsirolimus) | 8 | 10 |
| Total, serious adverse events | Regimen A (VAC/VI) | 17 | 155 |
| Total, serious adverse events | Regimen B (VAC/VI/Temsirolimus) | 77 | 153 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT02567435
GET https://conductscience.org/api/trials/v1/NCT02567435/events?page=2