TriangleNCT00354835 · STUDY IN CONTEXT
Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Probability of no relapse, secondary malignancy, or death after 4 year in the study
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.
Probability of being alive after 4 years in the study.
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- trial label
- Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- outcome key
- om-0000
- source section id
- NCT00354835-om-0000
- source outcome index
- 0
- endpoint
- Event Free Survival (EFS)
- endpoint definition
- Probability of no relapse, secondary malignancy, or death after 4 year in the study
- time origin
- 4 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- outcome key
- om-0001
- source section id
- NCT00354835-om-0001
- source outcome index
- 1
- endpoint
- Response Rate (RR)
- endpoint definition
- 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.
- time origin
- Reporting Period 1 (Weeks 1 - 15)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- outcome key
- om-0002
- source section id
- NCT00354835-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival (OS)
- endpoint definition
- Probability of being alive after 4 years in the study.
- time origin
- 4 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- outcome key
- om-0003
- source section id
- NCT00354835-om-0003
- source outcome index
- 3
- endpoint
- Event Free Survival (EFS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison
- endpoint definition
- 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.
- time origin
- 4 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 17 ineligible participants were excluded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- outcome key
- om-0004
- source section id
- NCT00354835-om-0004
- source outcome index
- 4
- endpoint
- Local Failure
- endpoint definition
- 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.
- time origin
- 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 17 ineligible participants were excluded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- outcome key
- om-0005
- source section id
- NCT00354835-om-0005
- source outcome index
- 5
- endpoint
- Overall Survival (OS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison
- endpoint definition
- 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.
- time origin
- 4 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 17 ineligible participants were excluded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Vincristine, Dactinomycin, Cyclophosphamide (VAC)
- regimen
- Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4. Dactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies
- analyzed count
- 222
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00354835-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- outcome key
- om-0000
- arm key
- OG001
- arm label
- VAC Alternating With Vincristine, Irinotecan (VI)
- regimen
- Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
- analyzed count
- 226
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00354835-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Vincristine, Dactinomycin, Cyclophosphamide (VAC)
- regimen
- Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
- analyzed count
- 222
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00354835-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- outcome key
- om-0001
- arm key
- OG001
- arm label
- VAC Alternating With Vincristine, Irinotecan (VI)
- regimen
- Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
- analyzed count
- 226
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00354835-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Vincristine, Dactinomycin, Cyclophosphamide (VAC)
- regimen
- Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
- analyzed count
- 222
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00354835-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- outcome key
- om-0002
- arm key
- OG001
- arm label
- VAC Alternating With Vincristine, Irinotecan (VI)
- regimen
- Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
- analyzed count
- 226
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00354835-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Vincristine, Dactinomycin, Cyclophosphamide (VAC)
- regimen
- Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
- analyzed count
- 222
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00354835-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Vincristine, Dactinomycin, Cyclophosphamide (VAC)
- regimen
- Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
- analyzed count
- 222
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00354835-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Vincristine, Dactinomycin, Cyclophosphamide (VAC)
- regimen
- Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
- analyzed count
- 222
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00354835-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- harm key
- EG000
- source section id
- NCT00354835-ae
- event group key
- EG000
- event group label
- Vincristine, Dactinomycin, Cyclophosphamide (VAC)
- serious affected
- 4
- serious at risk
- 222
- other affected
- 209
- other at risk
- 222
- frequency threshold
- 0
- collection period
- Source null
- event definition
- All eligible patients were considered in the evaluation of adverse events.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00354835
- harm key
- EG001
- source section id
- NCT00354835-ae
- event group key
- EG001
- event group label
- VAC Alternating With VI
- serious affected
- 11
- serious at risk
- 226
- other affected
- 213
- other at risk
- 226
- frequency threshold
- 0
- collection period
- Source null
- event definition
- All eligible patients were considered in the evaluation of adverse events.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice