At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma, botryoid or spindle cell variants, or embryonal ectomesenchymoma meeting low-risk criteria (Subset 1: Stage 1 Group I/II, Stage 1 Group III orbit only, or Stage 2 Group I/II; Subset 2: Stage 1 Group III non-orbit or Stage 3 Group I/II)
- ✓Performance status ECOG 0-2, or Karnofsky ≥50% (age ≥16), or Lansky ≥50% (age <16)
- ✓Absolute neutrophil count ≥750/mm³
- ✓Platelet count ≥75,000/mm³ (transfusion independent)
- ✕Intermediate-risk embryonal RMS, metastatic embryonal RMS, alveolar RMS, undifferentiated sarcoma, RMS NOS, or other soft tissue sarcoma
- ✕Prior enrollment on clinical trial COG-D9902
- ✕Prior chemotherapy (except patients treated on related intermediate-risk study)
- ✕Prior radiotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma
In Brief
A Phase 3 clinical trial evaluating conventional surgery, dactinomycin, and 3 other interventions for Adult Rhabdomyosarcoma and 3 related conditions. Completed, enrolled 390 participants across 163 sites in 6 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Some patients may undergo second-look surgery
Given IV
Given IV
Given IV
Undergo radiotherapy