Trial · NCT00354835
Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
NCT00354835, Phase 3, Completed, Children's Oncology Group; results first posted 2017-07-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma. Trials, record NCT00354835. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00354835
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
- NCT number
- NCT00354835
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 481 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
Adult Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma, Childhood Botryoid-Type Embryonal Rhabdomyosarcoma, Childhood Embryonal Rhabdomyosarcoma, Localized Childhood Soft Tissue Sarcoma, Rhabdomyosarcoma, Sarcoma, Stage I Adult Soft Tissue Sarcoma AJCC v7, Stage II Adult Soft Tissue Sarcoma AJCC v7, Stage III Adult Soft Tissue Sarcoma AJCC v7
- Interventions
- Cyclophosphamide, Dactinomycin, Irinotecan Hydrochloride, Laboratory Biomarker Analysis, Questionnaire Administration, Radiation Therapy, Vincristine Sulfate
- First posted
- 2006-07-20
- Last updated
- 2023-01-31
- Results first posted
- 2017-07-25
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event Free Survival (EFS) | 4 years | Probability of no relapse, secondary malignancy, or death after 4 year in the study |
| Primary | Response Rate (RR) | Reporting Period 1 (Weeks 1 - 15) | Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at \> 4 weeks; Partial Response (PR): At least 64% decrease in volume compared to the baseline; Overall Response (OR) = CR + PR. |
| Primary | Overall Survival (OS) | 4 years | Probability of being alive after 4 years in the study. |
| Secondary | Event Free Survival (EFS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison | 4 years | Compare 4-year EFS using eligible participants only to the historical rate of 0.65 with IRSI-V. The 4-year EFS is probability of no relapse, secondary malignancy, or death after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.65. |
| Secondary | Local Failure | 2 years | Compare 2-year local failure rate to the historical rate of 0.13 with IRSI-V. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.13. |
| Secondary | Overall Survival (OS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison | 4 years | Compare 4-year OS using eligible participants only to the historical rate of 0.70 with IRSI-V. The 4-year OS is probability of being alive after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.70. |
| Secondary | Incidence of Toxicity | Up to 15 weeks | Grade 3 or 4 nausea, diarrhea, dehydration, radiation dermatitis, mucositis due to radiation. Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3. |
| Secondary | Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC | Up to 43 weeks | The toxicity rates will be estimated for each phase and course of treatment, and will be compared to the fixed rates under D9803 using one-sided lower confidence intervals for a single proportion without adjustment for multiple comparisons. |
| Secondary | Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 4 | 4 years | 4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study). |
| Secondary | Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 15 | 4 years | 4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study) |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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) | 4 years | Probability | NUMBER | |
| PRIMARY | Response Rate (RR) | Reporting Period 1 (Weeks 1 - 15) | Proportion | NUMBER | |
| PRIMARY | Overall Survival (OS) | 4 years | Probability | NUMBER | |
| SECONDARY | Event Free Survival (EFS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison | 4 years | 17 ineligible participants were excluded. | Probability | NUMBER |
| SECONDARY | Local Failure | 2 years | 17 ineligible participants were excluded. | Proportion of participants | NUMBER |
| SECONDARY | Overall Survival (OS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison | 4 years | 17 ineligible participants were excluded. | Probability | NUMBER |
| SECONDARY | Incidence of Toxicity | Up to 15 weeks | Probability | NUMBER | |
| SECONDARY | Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC | Up to 43 weeks | Number of patients with specific adverse events. | participants | NUMBER |
| SECONDARY | Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 4 | 4 years | 452 participants were excluded due to ineligibility or absence of SUVmax evaluation at baseline and week 4. | Probability | NUMBER |
| SECONDARY | Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 15 | 4 years | 421 participants were excluded due to ineligibility or absence of SUVmax evaluation at baseline and week 15. | Probability | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group35
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) | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 0.6255 | 95% Confidence Interval 0.5575 to 0.6934 | Probability | |
| Event Free Survival (EFS) | VAC Alternating With Vincristine, Irinotecan (VI) | 0.5874 | 95% Confidence Interval 0.5178 to 0.6569 | Probability | |
| Response Rate (RR) | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 0.6667 | 95% Confidence Interval 0.6047 to 0.7287 | Proportion | |
| Response Rate (RR) | VAC Alternating With Vincristine, Irinotecan (VI) | 0.6726 | 95% Confidence Interval 0.6114 to 0.7337 | Proportion | |
| Overall Survival (OS) | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 0.7293 | 95% Confidence Interval 0.6669 to 0.7917 | Probability | |
| Overall Survival (OS) | VAC Alternating With Vincristine, Irinotecan (VI) | 0.7223 | 95% Confidence Interval 0.6583 to 0.7862 | Probability | |
| Event Free Survival (EFS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 0.6255 | 95% Confidence Interval 0.5575 to 0.6934 | Probability | |
| Local Failure | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 0.1757 | 95% Confidence Interval 0.1256 to 0.2257 | Proportion of participants | |
| Overall Survival (OS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 0.7293 | 95% Confidence Interval 0.6669 to 0.7917 | Probability | |
| Incidence of Toxicity | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 0.2072 | 95% Confidence Interval 0.1539 to 0.2605 | Probability |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 239 | |
| Overall Study | STARTED | VAC Alternating With Vincristine, Irinotecan (VI) | 242 | |
| Overall Study | COMPLETED | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 187 | |
| Overall Study | COMPLETED | VAC Alternating With Vincristine, Irinotecan (VI) | 181 | |
| Overall Study | NOT COMPLETED | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 52 | |
| Overall Study | NOT COMPLETED | VAC Alternating With Vincristine, Irinotecan (VI) | 61 |
Source ClinicalTrials.gov
Adverse events402
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 | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 0 | 222 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | VAC Alternating With VI | 2 | 226 | 2 |
| other | Abdominal infection | Infections and infestations | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 0 | 222 | 0 |
| other | Abdominal infection | Infections and infestations | VAC Alternating With VI | 2 | 226 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 9 | 222 | 11 |
| other | Abdominal pain | Gastrointestinal disorders | VAC Alternating With VI | 12 | 226 | 14 |
| other | Abducens nerve disorder | Nervous system disorders | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 0 | 222 | 0 |
| other | Abducens nerve disorder | Nervous system disorders | VAC Alternating With VI | 1 | 226 | 1 |
| other | Activated partial thromboplastin time prolonged | Investigations | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 1 | 222 | 1 |
| other | Activated partial thromboplastin time prolonged | Investigations | VAC Alternating With VI | 0 | 226 | 0 |
1 to 10 of 402Source ClinicalTrials.gov
See all 402 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | ||
| Total, all-cause mortality | VAC Alternating With VI | ||
| Total, other adverse events | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 209 | 222 |
| Total, other adverse events | VAC Alternating With VI | 213 | 226 |
| Total, serious adverse events | Vincristine, Dactinomycin, Cyclophosphamide (VAC) | 4 | 222 |
| Total, serious adverse events | VAC Alternating With VI | 11 | 226 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vincristine, Dactinomycin, Cyclophosphamide (VAC) vs VAC Alternating With VI: serious adverse events |
Source 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.
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/NCT00354835
GET https://conductscience.org/api/trials/v1/NCT00354835/results?page=2