Trial · NCT00354744
High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma
NCT00354744, Phase 3, Completed, Children's Oncology Group; results first posted 2014-01-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma. Trials, record NCT00354744. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00354744
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma
- NCT number
- NCT00354744
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 109 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Sarcoma
- Interventions
- dactinomycin, cyclophosphamide, doxorubicin hydrochloride, etoposide, ifosfamide, irinotecan hydrochloride, vincristine sulfate, conventional surgery, radiation therapy, filgrastim
- First posted
- 2006-07-20
- Last updated
- 2020-01-29
- Results first posted
- 2014-01-10
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Complete or Partial Response Assessed by RECIST Criteria | Protocol week 6 evaluation | Volumetric measurements of the primary tumor using an elliptical model (0.5 x the product of the 3 largest perpendicular diameters) to assess response to neoadjuvant therapy. The RECIST (Response Evaluation Criteria in Solid Tumors) from the NCI will be used for assessment of the size of measurable metastases, including nodal metastases. Primary Tumor Measurement: Technical guidelines for cross-sectional imaging computed tomography (CT) slice thickness should be 5mm or less and the diameter of the "measurable" mass should be at least twice the reconstructed slice thickness. Smaller masses are considered detectable, but will be counted as "non-measurable." Complete Response (CR): Complete disappearance of the tumor confirmed at \>4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Progressive Disease (PD): At least 40% increase in tumor volume compared to the smallest volume obtained since the beginning. |
| Primary | Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy | From enrollment to up to 2 years | Adverse events are reported for patients receiving concurrent irinotecan hydrochloride and radiotherapy. |
| Secondary | Percentage of Patients Event Free at 4 Years Following Study Entry | 4 years | Event-free survival: Time to recurrence, second malignancy, or death as a first event, estimated from a Kaplan Meier curve |
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 | Number of Patients With Complete or Partial Response Assessed by RECIST Criteria | Protocol week 6 evaluation | All eligible patients with protocol week tumor assessment (N=102) | percentage of participants | NUMBER |
| PRIMARY | Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy | From enrollment to up to 2 years | Percentage of patients experiencing a grade 3/4/5 toxicity in a course. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Event Free at 4 Years Following Study Entry | 4 years | All eligible patients | Percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Complete or Partial Response Assessed by RECIST Criteria | High_Risk_Rhabdomyosarcoma | 63 | percentage of participants | ||
| Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy | High_Risk_Rhabdomyosarcoma | Course 1 | 53.3 | 95% Confidence Interval 43.4 to 63.0 | percentage of patients |
| Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy | High_Risk_Rhabdomyosarcoma | Course 2 | 68.4 | 95% Confidence Interval 58.2 to 77.4 | percentage of patients |
| Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy | High_Risk_Rhabdomyosarcoma | Course 3 | 79.3 | 95% Confidence Interval 69.3 to 87.3 | percentage of patients |
| Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy | High_Risk_Rhabdomyosarcoma | Course 4 | 55.7 | 95% Confidence Interval 43.3 to 67.6 | percentage of patients |
| Percentage of Patients Event Free at 4 Years Following Study Entry | High_Risk_Rhabdomyosarcoma | 36 | 95% Confidence Interval 27 to 46 | Percentage of patients |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | High_Risk_Rhabdomyosarcoma | 109 | |
| Overall Study | COMPLETED | High_Risk_Rhabdomyosarcoma | 67 | |
| Overall Study | NOT COMPLETED | High_Risk_Rhabdomyosarcoma | 42 |
Source ClinicalTrials.gov
Adverse events145
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 | High_Risk_Rhabdomyosarcoma | 1 | 108 | |
| other | Abdominal infection | Infections and infestations | High_Risk_Rhabdomyosarcoma | 2 | 108 | |
| other | Abdominal pain | Gastrointestinal disorders | High_Risk_Rhabdomyosarcoma | 15 | 108 | |
| other | Acidosis | Metabolism and nutrition disorders | High_Risk_Rhabdomyosarcoma | 1 | 108 | |
| other | Activated partial thromboplastin time prolonged | Investigations | High_Risk_Rhabdomyosarcoma | 1 | 108 | |
| other | Acute kidney injury | Renal and urinary disorders | High_Risk_Rhabdomyosarcoma | 1 | 108 | |
| other | Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | High_Risk_Rhabdomyosarcoma | 1 | 108 | |
| other | Alanine aminotransferase increased | Investigations | High_Risk_Rhabdomyosarcoma | 12 | 108 | |
| other | Alkalosis | Metabolism and nutrition disorders | High_Risk_Rhabdomyosarcoma | 1 | 108 | |
| other | Anal pain | Gastrointestinal disorders | High_Risk_Rhabdomyosarcoma | 3 | 108 |
1 to 10 of 145Source ClinicalTrials.gov
See all 145 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High_Risk_Rhabdomyosarcoma | ||
| Total, other adverse events | High_Risk_Rhabdomyosarcoma | 95 | 108 |
| Total, serious adverse events | High_Risk_Rhabdomyosarcoma | 4 | 108 |
Source ClinicalTrials.gov
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.
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/NCT00354744
GET https://conductscience.org/api/trials/v1/NCT00354744/events?page=2