Combination Chemotherapy in Treating Young Patients With Nonmetastatic Rhabdomyosarcoma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating rhabdomyosarcoma.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with nonmetastatic rhabdomyosarcoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Paediatric Soft Tissue Sarcoma Study Group
• Collaborators: Children's Cancer and Leukaemia Group; Dutch Childhood Oncology Group; Italian Association for Pediatric Hematology Oncology
• Treatments: Carboplatin; Cyclophosphamide; Dactinomycin; Doxorubicin; Etoposide; Ifosfamide; Liposomal doxorubicin; Topotecan; Vincristine; Vinorelbine

Criteria

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