Under 49, any sex, with Adult Rhabdomyosarcoma or Embryonal Childhood Rhabdomyosarcoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study EntryPrimary· From enrollment up to 5 years
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.
Group
Value
95% CI
Regimen I (Chemotherapy, Radiotherapy)
87
82 – 91
Regimen II (Chemotherapy, Radiotherapy, Surgery)
67
52 – 79
Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Failure Free at 5 Years Following Study EntryPrimary· From enrollment up to 5 years
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.
Group
Value
95% CI
Regimen I (Chemotherapy, Radiotherapy)
90
72 – 97
Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study EntryPrimary· From enrollment up to 5 years
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.
Group
Value
95% CI
Regimen II (Chemotherapy, Radiotherapy, Surgery)
67
52 – 79
Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation TherapySecondary· From enrollment up to 5 years
The local failure rate will be estimated using cumulative incidence curves.
Group
Value
95% CI
Regimen I (Chemotherapy, Radiotherapy)
0.081
0.046 – 0.116
Regimen II (Chemotherapy, Radiotherapy, Surgery)
0.115
0.035 – 0.195
Percentage of Patients With Delayed Surgical ProceduresSecondary· At 13 weeks after induction
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.
Group
Value
95% CI
Regimen II (Stage I Group III Nonorbit or Stage III Group I/II
0.49
0.34 – 0.64
Cumulative Incidence of Group III Patients Who Received With Reduced Radiotherapy DoseSecondary· From enrollment up to 20 weeks
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.
Group
Value
95% CI
Regimen II (Stage I Group III Nonorbit or Stage III Group I/II
0
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Regimen I (Chemotherapy, Radiotherapy)
Serious: 1/272 (0%)
Deaths: —
Regimen II (Chemotherapy, Radiotherapy, Surgery)
Serious: 1/70 (1%)
Deaths: —
Serious adverse events (2 terms)
Reaction
System
Regimen I (Chemotherapy, R…
Regimen II (Chemotherapy, …
Neutrophil count decreased
Investigations
—
—
White blood cell decreased
Investigations
—
—
Other adverse events (60 terms — click to expand)
Reaction
System
Regimen I (Chemotherapy, R…
Regimen II (Chemotherapy, …
Neutrophil count decreased
Investigations
—
—
White blood cell decreased
Investigations
—
—
Anemia
Blood and lymphatic system disorders
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Platelet count decreased
Investigations
—
—
Alanine aminotransferase increased
Investigations
—
—
Aspartate aminotransferase increased
Investigations
—
—
Vomiting
Gastrointestinal disorders
—
—
Fever
General disorders
—
—
Infections and infestations - Other
Infections and infestations
—
—
Hyperglycemia
Metabolism and nutrition disorders
—
—
Peripheral motor neuropathy
Nervous system disorders
—
—
Peripheral sensory neuropathy
Nervous system disorders
—
—
Constipation
Gastrointestinal disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Lymphocyte count decreased
Investigations
—
—
Weight loss
Investigations
—
—
Skin and subcutaneous tissue disorders - Other, specify
This phase III trial is studying how well combination chemotherapy and radiation therapy work in treating patients with newly diagnosed low-risk rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective in treating low-risk rhabdomyosarcoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· completed
NCT06240182 — Effect of Piezoelectric Device on Intraoperative Hemorrhage Control and Quality of Life
· NA
· unknown
NCT03266549 — Botulinum Toxin Augmented Surgery vs Conventional Surgery in the Management of Large Angle Horizontal Deviations
· NA
· unknown
NCT06971653 — Effect of Piezoelectric Surgery on Pain, Comfort, and Patient Satisfaction in Third Molar Surgery
· NA
· completed
NCT06965855 — Effect of Piezoelectric Surgery onPostoperative Complications in Third Molar Surgery
· NA
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Children's Oncology Group
Last refreshed: 19 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00075582.