Status:
UNKNOWN
Combination Chemotherapy in Treating Young Patients With Nonmetastatic Rhabdomyosarcoma
Lead Sponsor:
European Paediatric Soft Tissue Sarcoma Study Group
Collaborating Sponsors:
Italian Association for Pediatric Hematology Oncology
Children's Cancer and Leukaemia Group
Conditions:
Sarcoma
Eligibility:
All Genders
Up to 20 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination ch...
Detailed Description
OBJECTIVES: * Improve the outcome in pediatric patients with low-risk rhabdomyosarcoma (RMS) treated with vincristine and dactinomycin alone. * Evaluate whether the outcome for older patients with st...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed rhabdomyosarcoma (RMS) or other malignant mesenchymal tumor, including undifferentiated soft tissue sarcoma or ectomesenchymoma
- Has undergone diagnostic surgery within the past 8 weeks
- Meets criteria for 1 of the following risk groups:
- Low-risk group
- Localized nonalveolar RMS at any site
- Embryonal, spindle cell, or botryoid RMS (favorable pathology)
- Microscopically completely resected disease (Intergroup Rhabdomyosarcoma Study \[IRS\] group I)
- Negative nodes (N0)
- Tumor size ≤ 5 cm AND age \< 10 years (favorable tumor size and age)
- Standard-risk group, meeting criteria for 1 of the following subgroups:
- Subgroup B
- Localized nonalveolar RMS at any site
- Favorable pathology
- Microscopically completely resected disease (IRS group I)
- N0 disease
- Tumor size \> 5 cm OR age ≥ 10 years (unfavorable tumor size or age)
- Subgroup C
- Localized nonalveolar RMS in orbit, head and neck nonparameningeal sites, or genitourinary (GU) non bladder prostate (i.e., paratesticular and vagina/uterus) sites (favorable site)
- Favorable pathology
- Microscopic residual disease (pT3a) or completely resected disease with nodal involvement (N1) (IRS group II) OR macroscopic residual disease (pT3b) (IRS group III)
- N0 disease
- Any tumor size or age
- Subgroup D
- Localized nonalveolar RMS in parameningeal sites, extremities, GU bladder prostate sites, or other sites (unfavorable site)
- Favorable pathology
- IRS group II or III
- N0 disease
- Favorable tumor size and age
- High-risk group, meeting criteria for 1 of the following subgroups:
- Subgroup E
- Localized nonalveolar RMS at unfavorable site
- Favorable pathology
- IRS group II or III
- N0 disease
- Unfavorable tumor size or age
- Subgroup F
- Localized nonalveolar RMS at any site
- Favorable pathology
- IRS group I, II, or III
- Positive nodes (N1)
- Any tumor size or age
- Subgroup G
- Localized alveolar RMS at any site
- Alveolar RMS, including the solid-alveolar variant (unfavorable pathology)
- IRS group I, II, or III
- N0 disease
- Any tumor size or age
- Very high-risk group
- Localized alveolar RMS at any site
- Unfavorable pathology
- IRS group I, II, or III
- N1 disease
- Any tumor size or age
- Previously untreated disease (except for primary surgery)
- No evidence of metastatic disease
- PATIENT CHARACTERISTICS:
- Shortening fraction \> 28%
- Ejection fraction \> 47%
- No prior cardiac disease
- Renal function must be equivalent to grade 0-1 nephrotoxicity
- No prior malignant tumors
- No pre-existing illness preventing treatment
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00379457
Start Date
June 1 2006
Last Update
August 12 2013
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Anna Children's Hospital
Vienna, Austria, A-1090
2
Hopital Universitaire Des Enfants Reine Fabiola
Brussels, Belgium, 1020
3
Rigshospitalet - Copenhagen University Hospital
Copenhagen, Denmark, 2100
4
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12