Phase 3
N=390
Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
Adult Rhabdomyosarcoma · Embryonal Childhood Rhabdomyosarcoma · Embryonal-botryoid Childhood Rhabdomyosarcoma · Previously Untreated Childhood Rhabdomyosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00075582 ↗Enrolled (actual)
390
Serious AEs
0.6%
Results posted
Apr 2014
Primary outcome: Primary: Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry — 87; 67 Estimated percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- conventional surgery (Procedure); dactinomycin (Drug); cyclophosphamide (Drug); vincristine sulfate (Drug); radiation therapy (Radiation)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry |
87; 67 | — |
| PRIMARY Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Failure Free at 5 Years Following Study Entry |
90 | — |
| PRIMARY Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry |
67 | — |
| SECONDARY Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy |
0.081; 0.115 | — |
| SECONDARY Percentage of Patients With Delayed Surgical Procedures |
0.49 | — |
| SECONDARY Cumulative Incidence of Group III Patients Who Received With Reduced Radiotherapy Dose |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma (RMS), botryoid or spindle cell variants of embryonal RMS, or embryonal ectomesenchymoma, meeting criteria for 1 of the following subsets:
- Subset 1, defined by meeting 1 of the following criteria (closed to accrual as of 08/13/2010):
- Stage 1 and clinical group I (completely resected) or II (microscopic residual disease and/or regional lymph node involvement) disease
- Stage 1 and clinical group III (gross residual disease) disease arising in the orbit
- Stage 2 and clinical group I or II disease
- Subset 2, defined by meeting 1 of the following criteria (closed to accrual as of 09/23/2011):
- Stage 1 and clinical group III disease arising in a non-orbit site
- Stage 3 and clinical group I or II disease
- Prior staging ipsilateral retroperitoneal lymph node dissection required for all patients age 10 and over with paratesticular tumors and patients under 10 years of age with clinically or radiographically involved lymph nodes (except when extensive lymph node involvement is identified by imaging studies)
- If there is extensive gross node involvement only confirmatory node biopsy is recommended and the patient is classified as Clinical Group III
- Prior regional lymph node sampling required for patients with extremity tumors
- None of the following diagnoses:
- Intermediate-risk embryonal RMS
- Metastatic embryonal RMS
- Alveolar RMS
- Undifferentiated sarcoma
- RMS not otherwise specified (NOS)
- Other soft tissue sarcoma, including sarcoma NOS
- Prior enrollment on clinical trial COG-D9902
- Performance status - ECOG 0-2
- Performance status - Karnofsky 50-100% (≥ 16 years old)
- Performance status - Lansky 50-100% (< 16 years old)
- Absolute neutrophil count at least 750/mm^3
- Platelet count at least 75, 000/mm^3 (transfusion independent)
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)*
- Creatinine* based on age/gender as follows:
- No greater than 0.8 mg/dL for patients age 5 and under
- No greater than 1.0 mg/dL for patients age 6 to 9
- No greater than 1.2 mg/dL for patients age 10 to 12
- No greater than 1.4 mg/dL for female patients age 13 and over
- No greater than 1.5 mg/dL for male patients age 13 to 15
- No greater than 1.7 mg/dL for male patients age 16 and over
- Creatinine clearance* or radioisotope glomerular filtration rate at least 70 mL/min/1.73 m^2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infection
- No prior chemotherapy (except for patients treated on the related intermediate-risk study)
- Prior steroids allowed
- No prior radiotherapy
Data sourced from ClinicalTrials.gov (NCT00075582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.