TriangleNCT00075582 · STUDY IN CONTEXT
Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk 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
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
The local failure rate will be estimated using cumulative incidence curves.
The decision to perform second-look surgery should be based on the physical examination and imaging studies at Week 12 and should only be considered if a reasonable functional and cosmetic result is anticipated.
The local failure rate will be estimated using cumulative incidence curves for Group III patients who received reduced doses of radiation therapy after second look surgical resection.
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-rhabdomyosarcoma-pediatric
- nct id
- NCT00075582
- trial label
- Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk 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-rhabdomyosarcoma-pediatric
- nct id
- NCT00075582
- outcome key
- om-0000
- source section id
- NCT00075582-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry
- endpoint definition
- Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
- time origin
- From enrollment up to 5 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
- 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-rhabdomyosarcoma-pediatric
- nct id
- NCT00075582
- outcome key
- om-0001
- source section id
- NCT00075582-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Failure Free at 5 Years Following Study Entry
- endpoint definition
- Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
- time origin
- From enrollment up to 5 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients among this subset of regimen 1 patients were included in this outcome measure restricted to regimen 1 patients (there were 36 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.
- 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-rhabdomyosarcoma-pediatric
- nct id
- NCT00075582
- outcome key
- om-0002
- source section id
- NCT00075582-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry
- endpoint definition
- Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
- time origin
- From enrollment up to 5 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients among this subset of regimen 2 patients were included in this outcome measure to regimen 2 patients (there were 16 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.
- 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-rhabdomyosarcoma-pediatric
- nct id
- NCT00075582
- outcome key
- om-0003
- source section id
- NCT00075582-om-0003
- source outcome index
- 3
- endpoint
- Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy
- endpoint definition
- The local failure rate will be estimated using cumulative incidence curves.
- time origin
- From enrollment up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who received reduced doses of radiation therapy.
- 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-rhabdomyosarcoma-pediatric
- nct id
- NCT00075582
- outcome key
- om-0004
- source section id
- NCT00075582-om-0004
- source outcome index
- 4
- endpoint
- Percentage of Patients With Delayed Surgical Procedures
- endpoint definition
- The decision to perform second-look surgery should be based on the physical examination and imaging studies at Week 12 and should only be considered if a reasonable functional and cosmetic result is anticipated.
- time origin
- At 13 weeks after induction
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible Stage I Group III nonorbit primary and stage III group I/II patients
- 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-rhabdomyosarcoma-pediatric
- nct id
- NCT00075582
- outcome key
- om-0005
- source section id
- NCT00075582-om-0005
- source outcome index
- 5
- endpoint
- Cumulative Incidence of Group III Patients Who Received With Reduced Radiotherapy Dose
- endpoint definition
- The local failure rate will be estimated using cumulative incidence curves for Group III patients who received reduced doses of radiation therapy after second look surgical resection.
- time origin
- From enrollment up to 20 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients with Group III vaginal primary tumor
- 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-rhabdomyosarcoma-pediatric
- nct id
- NCT00075582
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Regimen I (Chemotherapy, Radiotherapy)
- regimen
- Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
- analyzed count
- 269
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075582-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdomyosarcoma-pediatric
- nct id
- NCT00075582
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Regimen II (Chemotherapy, Radiotherapy, Surgery)
- regimen
- Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011). conventional surgery: Some patients may undergo second-look surgery dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
- analyzed count
- 69
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075582-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdomyosarcoma-pediatric
- nct id
- NCT00075582
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Regimen I (Chemotherapy, Radiotherapy)
- regimen
- Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075582-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdomyosarcoma-pediatric
- nct id
- NCT00075582
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Regimen II (Chemotherapy, Radiotherapy, Surgery)
- regimen
- Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011). conventional surgery: Some patients may undergo second-look surgery dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
- analyzed count
- 69
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075582-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdomyosarcoma-pediatric
- nct id
- NCT00075582
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Regimen I (Chemotherapy, Radiotherapy)
- regimen
- Stage I/II group IIA patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
- analyzed count
- 52
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075582-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdomyosarcoma-pediatric
- nct id
- NCT00075582
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Regimen II (Chemotherapy, Radiotherapy, Surgery)
- regimen
- Group III patients with orbit primary receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
- analyzed count
- 62
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075582-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdomyosarcoma-pediatric
- nct id
- NCT00075582
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Regimen II (Stage I Group III Nonorbit or Stage III Group I/II
- regimen
- Stage I group III nonorbit primary or stage III group I/II patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075582-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdomyosarcoma-pediatric
- nct id
- NCT00075582
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Regimen II (Stage I Group III Nonorbit or Stage III Group I/II
- regimen
- Stage I group III nonorbit primary or stage III group I/II patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075582-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdomyosarcoma-pediatric
- nct id
- NCT00075582
- harm key
- EG000
- source section id
- NCT00075582-ae
- event group key
- EG000
- event group label
- Regimen I (Chemotherapy, Radiotherapy)
- serious affected
- 1
- serious at risk
- 272
- other affected
- 74
- other at risk
- 272
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
- 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-rhabdomyosarcoma-pediatric
- nct id
- NCT00075582
- harm key
- EG001
- source section id
- NCT00075582-ae
- event group key
- EG001
- event group label
- Regimen II (Chemotherapy, Radiotherapy, Surgery)
- serious affected
- 1
- serious at risk
- 70
- other affected
- 27
- other at risk
- 70
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
- 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