Combination Chemotherapy in Treating Young Patients With Nonmetastatic Rhabdomyosarcoma
NCT ID: NCT00379457
Last Updated: 2013-08-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE3
Total Enrollment
600 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-06-30
Brief Summary
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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.
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.
Detailed Description
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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 standard-risk RMS with favorable features may be improved/maintained by administering a treatment with limited intensity.
* Evaluate whether chemotherapy intensity for patients with standard-risk RMS can be reduced, by lowering the cumulative dose of ifosfamide.
* Evaluate whether treatment can be reduced in a subgroup of patients with standard-risk RMS arising in an unfavorable site (e.g., parameningeal or other site) but with favorable site and age.
* Compare the value of standard chemotherapy comprising ifosfamide, vincristine, and dactinomycin with vs without doxorubicin (as early intensification in the initial part of treatment) in patients with high-risk RMS.
* Determine the role of low-dose maintenance chemotherapy comprising 6 months of cyclophosphamide and vinorelbine in patients with high-risk RMS.
* Improve the results in patients with poor prognosis (very high-risk) RMS treated with more intensive ifosfamide, vincristine, dactinomycin, and doxorubicin followed by maintenance chemotherapy.
OUTLINE: This is a non-blinded, randomized, prospective, multicenter study. Patients are stratified according to risk group (low risk vs standard risk vs high risk vs very high risk) and participating country.
* Stratum 1 (low-risk group): Patients receive vincristine IV on day 1 in weeks 1-4, 7-10, 13-16, and 19-22 and dactinomycin IV on day 1 in weeks 1, 4, 7, 10, 13, 16, 19, and 22.
* Stratum 2 (standard-risk group): Patients are assigned to 1 of 3 treatment groups according to their standard-risk subgroup.
* Subgroup B: Patients receive ifosfamide IV over 3 hours on days 1 and 2 in weeks 1, 4, 7, and 10; vincristine IV on day 1 in weeks 1-7, 10, 13, 16, 19, 22, and 25; and dactinomycin IV on day 1 in weeks 1, 4, 7, 10, 13, 16, 19, 22, and 25.
* Subgroup C: Patients receive ifosfamide IV over 3 hours on days 1 and 2 in weeks 1, 4, and 7; vincristine IV on day 1 in weeks 1-7; and dactinomycin IV on day 1 in weeks 1, 4, and 7. Patients are evaluated for tumor response in week 9. Patients in complete remission (CR) with favorable age and tumor size continue to receive ifosfamide, vincristine, and dactinomycin as above in weeks 10, 13, 16\*, 19, 22, and 25. Patients may also undergo radiotherapy beginning in week 13 and continuing for 5-6 weeks. Patients in CR with unfavorable age or tumor size OR in partial remission (PR) (i.e., \> 1/3 tumor volume reduction) continue to receive ifosfamide as above in weeks 10 and 16 and vincristine and dactinomycin as above in weeks 10, 13, 16\*, 19, 22, and 25. These patients also undergo radiotherapy beginning in week 13 and continuing for 5-6 weeks. Patients with stable or progressive disease in week 9 proceed to second-line therapy and radiotherapy. Patients with residual disease after completion of chemotherapy in week 10 undergo surgical resection followed by ifosfamide, vincristine, and dactinomycin (with or without radiotherapy) as above in weeks 13, 16\*, 19, 22, and 25.
* Subgroup D: Patients receive ifosfamide IV over 3 hours on days 1 and 2 in weeks 1, 4, and 7; vincristine IV on day 1 in weeks 1-7; and dactinomycin IV on day 1 in weeks 1, 4, and 7. Patients are evaluated for tumor response in week 9. Patients in CR or PR continue to receive ifosfamide, vincristine, and dactinomycin as above in weeks 10, 13, 16\*, 19, 22, and 25. Patients may also undergo radiotherapy beginning in week 13 and continuing for 5-6 weeks. Patients with stable or progressive disease in week 9 proceed to second-line therapy and radiotherapy. Patients with residual disease after completion of chemotherapy in week 10 undergo surgical resection followed by ifosfamide, vincristine, and dactinomycin (with or without radiotherapy) as above in weeks 13, 16\*, 19, 22, and 25.
NOTE: \*Dactinomycin may be omitted during radiotherapy in week 16.
* Stratum 3 (high-risk group): Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive ifosfamide, vincristine, and dactinomycin as in subgroups C and D of stratum 2. Patients are evaluated for tumor response in week 9. Patients in CR or PR continue to receive ifosfamide, vincristine, and dactinomycin as in subgroups C and D of stratum 2. Patients may also undergo radiotherapy beginning in week 13 and continuing for 5-6 weeks. Patients with stable or progressive disease in week 9 proceed to second-line therapy and radiotherapy. Patients with residual disease after completion of chemotherapy in week 10 undergo surgical resection followed by ifosfamide, vincristine, and dactinomycin (with or without radiotherapy) as above in weeks 13, 16\*, 19, 22, and 25.
* Arm II: Patients receive ifosfamide, vincristine, and dactinomycin as in subgroups C and D of stratum 2. Patients also receive doxorubicin IV over 4 hours on days 1 and 2 in weeks 1, 4, and 7. Patients are evaluated for tumor response in week 9. Patients in CR or PR continue to receive ifosfamide, vincristine, dactinomycin, and doxorubicin as above in week 10 and then ifosfamide, vincristine, and dactinomycin as above in weeks 13, 16\*, 19, 22, and 25. Patients may also undergo radiotherapy beginning in week 13 and continuing for 5-6 weeks. Patients with stable or progressive disease in week 9 proceed to second-line therapy and radiotherapy. Patients with residual disease after completion of chemotherapy in week 10 undergo surgical resection followed by ifosfamide, vincristine, and dactinomycin (with or without radiotherapy) as above in weeks 13, 16\*, 19, 22, and 25.
NOTE: \*Dactinomycin may be omitted during radiotherapy in week 16.
* Maintenance chemotherapy: Patients who remain in CR or with minimal abnormalities on imaging studies after completion of therapy according to their randomized arm (as above) undergo a second randomization. Randomization occurs within 6 weeks after administration of the last course of chemotherapy on arm I or II.
* Arm I: Patients receive no maintenance chemotherapy.
* Arm II: Patients receive vinorelbine IV over 5-10 minutes on days 1, 8, and 15 and oral cyclophosphamide once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses.
* Stratum 4 (very high-risk group): Patients receive ifosfamide, vincristine, and dactinomycin as in subgroups C and D of stratum 2. Patients also receive doxorubicin as in arm II of stratum 3. Patients are evaluated for tumor response in week 9. Patients in CR or PR continue to receive ifosfamide, vincristine, dactinomycin, and doxorubicin as in arm II of stratum 3. Patients may also undergo radiotherapy beginning in week 13 and continuing for 5-6 weeks. Patients with stable or progressive disease in week 9 proceed to second-line therapy and radiotherapy. Patients with residual disease after completion of chemotherapy in week 10 undergo surgical resection followed by ifosfamide, vincristine, and dactinomycin (with or without radiotherapy) as above in weeks 13, 16, 19, 22, and 25. After completion of chemotherapy, patients with a limited quantity of viable tumor proceed to maintenance chemotherapy.
* Maintenance chemotherapy: Patients receive vinorelbine IV over 5-10 minutes on days 1, 8, and 15 and oral cyclophosphamide once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses.
* Second-line therapy: Patients in any stratum with stable or progressive disease in week 9 receive 1 of 2 second-line therapy regimens.
* Regimen 1: Patients receive topotecan IV on days 1-3 and carboplatin IV on days 4 and 5 in weeks 1 and 4. Patients are then evaluated for tumor response. Patients with good response receive topotecan IV on days 1-3 and cyclophosphamide IV on days 1 and 2 in weeks 7 and 13 and etoposide IV on days 1-3 and carboplatin IV on days 4 and 5 in weeks 10 and 16. Patients with no response receive local therapy or a new chemotherapy regimen.
* Regimen 2: Patients receive doxorubicin IV on day 1 and carboplatin IV on days 1 and 2 in weeks 1 and 4. Patients are then evaluated for tumor response. Patients with good response receive doxorubicin IV on day 1 in weeks 7, 10, 13, and 16; cyclophosphamide IV on days 1 and 2 in weeks 7 and 13; and carboplatin IV on days 1 and 2 of weeks 10 and 16. Patients with no response receive local therapy or a new chemotherapy regimen.
After completion of therapy, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.
* 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 standard-risk RMS with favorable features may be improved/maintained by administering a treatment with limited intensity.
* Evaluate whether chemotherapy intensity for patients with standard-risk RMS can be reduced, by lowering the cumulative dose of ifosfamide.
* Evaluate whether treatment can be reduced in a subgroup of patients with standard-risk RMS arising in an unfavorable site (e.g., parameningeal or other site) but with favorable site and age.
* Compare the value of standard chemotherapy comprising ifosfamide, vincristine, and dactinomycin with vs without doxorubicin (as early intensification in the initial part of treatment) in patients with high-risk RMS.
* Determine the role of low-dose maintenance chemotherapy comprising 6 months of cyclophosphamide and vinorelbine in patients with high-risk RMS.
* Improve the results in patients with poor prognosis (very high-risk) RMS treated with more intensive ifosfamide, vincristine, dactinomycin, and doxorubicin followed by maintenance chemotherapy.
OUTLINE: This is a non-blinded, randomized, prospective, multicenter study. Patients are stratified according to risk group (low risk vs standard risk vs high risk vs very high risk) and participating country.
* Stratum 1 (low-risk group): Patients receive vincristine IV on day 1 in weeks 1-4, 7-10, 13-16, and 19-22 and dactinomycin IV on day 1 in weeks 1, 4, 7, 10, 13, 16, 19, and 22.
* Stratum 2 (standard-risk group): Patients are assigned to 1 of 3 treatment groups according to their standard-risk subgroup.
* Subgroup B: Patients receive ifosfamide IV over 3 hours on days 1 and 2 in weeks 1, 4, 7, and 10; vincristine IV on day 1 in weeks 1-7, 10, 13, 16, 19, 22, and 25; and dactinomycin IV on day 1 in weeks 1, 4, 7, 10, 13, 16, 19, 22, and 25.
* Subgroup C: Patients receive ifosfamide IV over 3 hours on days 1 and 2 in weeks 1, 4, and 7; vincristine IV on day 1 in weeks 1-7; and dactinomycin IV on day 1 in weeks 1, 4, and 7. Patients are evaluated for tumor response in week 9. Patients in complete remission (CR) with favorable age and tumor size continue to receive ifosfamide, vincristine, and dactinomycin as above in weeks 10, 13, 16\*, 19, 22, and 25. Patients may also undergo radiotherapy beginning in week 13 and continuing for 5-6 weeks. Patients in CR with unfavorable age or tumor size OR in partial remission (PR) (i.e., \> 1/3 tumor volume reduction) continue to receive ifosfamide as above in weeks 10 and 16 and vincristine and dactinomycin as above in weeks 10, 13, 16\*, 19, 22, and 25. These patients also undergo radiotherapy beginning in week 13 and continuing for 5-6 weeks. Patients with stable or progressive disease in week 9 proceed to second-line therapy and radiotherapy. Patients with residual disease after completion of chemotherapy in week 10 undergo surgical resection followed by ifosfamide, vincristine, and dactinomycin (with or without radiotherapy) as above in weeks 13, 16\*, 19, 22, and 25.
* Subgroup D: Patients receive ifosfamide IV over 3 hours on days 1 and 2 in weeks 1, 4, and 7; vincristine IV on day 1 in weeks 1-7; and dactinomycin IV on day 1 in weeks 1, 4, and 7. Patients are evaluated for tumor response in week 9. Patients in CR or PR continue to receive ifosfamide, vincristine, and dactinomycin as above in weeks 10, 13, 16\*, 19, 22, and 25. Patients may also undergo radiotherapy beginning in week 13 and continuing for 5-6 weeks. Patients with stable or progressive disease in week 9 proceed to second-line therapy and radiotherapy. Patients with residual disease after completion of chemotherapy in week 10 undergo surgical resection followed by ifosfamide, vincristine, and dactinomycin (with or without radiotherapy) as above in weeks 13, 16\*, 19, 22, and 25.
NOTE: \*Dactinomycin may be omitted during radiotherapy in week 16.
* Stratum 3 (high-risk group): Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive ifosfamide, vincristine, and dactinomycin as in subgroups C and D of stratum 2. Patients are evaluated for tumor response in week 9. Patients in CR or PR continue to receive ifosfamide, vincristine, and dactinomycin as in subgroups C and D of stratum 2. Patients may also undergo radiotherapy beginning in week 13 and continuing for 5-6 weeks. Patients with stable or progressive disease in week 9 proceed to second-line therapy and radiotherapy. Patients with residual disease after completion of chemotherapy in week 10 undergo surgical resection followed by ifosfamide, vincristine, and dactinomycin (with or without radiotherapy) as above in weeks 13, 16\*, 19, 22, and 25.
* Arm II: Patients receive ifosfamide, vincristine, and dactinomycin as in subgroups C and D of stratum 2. Patients also receive doxorubicin IV over 4 hours on days 1 and 2 in weeks 1, 4, and 7. Patients are evaluated for tumor response in week 9. Patients in CR or PR continue to receive ifosfamide, vincristine, dactinomycin, and doxorubicin as above in week 10 and then ifosfamide, vincristine, and dactinomycin as above in weeks 13, 16\*, 19, 22, and 25. Patients may also undergo radiotherapy beginning in week 13 and continuing for 5-6 weeks. Patients with stable or progressive disease in week 9 proceed to second-line therapy and radiotherapy. Patients with residual disease after completion of chemotherapy in week 10 undergo surgical resection followed by ifosfamide, vincristine, and dactinomycin (with or without radiotherapy) as above in weeks 13, 16\*, 19, 22, and 25.
NOTE: \*Dactinomycin may be omitted during radiotherapy in week 16.
* Maintenance chemotherapy: Patients who remain in CR or with minimal abnormalities on imaging studies after completion of therapy according to their randomized arm (as above) undergo a second randomization. Randomization occurs within 6 weeks after administration of the last course of chemotherapy on arm I or II.
* Arm I: Patients receive no maintenance chemotherapy.
* Arm II: Patients receive vinorelbine IV over 5-10 minutes on days 1, 8, and 15 and oral cyclophosphamide once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses.
* Stratum 4 (very high-risk group): Patients receive ifosfamide, vincristine, and dactinomycin as in subgroups C and D of stratum 2. Patients also receive doxorubicin as in arm II of stratum 3. Patients are evaluated for tumor response in week 9. Patients in CR or PR continue to receive ifosfamide, vincristine, dactinomycin, and doxorubicin as in arm II of stratum 3. Patients may also undergo radiotherapy beginning in week 13 and continuing for 5-6 weeks. Patients with stable or progressive disease in week 9 proceed to second-line therapy and radiotherapy. Patients with residual disease after completion of chemotherapy in week 10 undergo surgical resection followed by ifosfamide, vincristine, and dactinomycin (with or without radiotherapy) as above in weeks 13, 16, 19, 22, and 25. After completion of chemotherapy, patients with a limited quantity of viable tumor proceed to maintenance chemotherapy.
* Maintenance chemotherapy: Patients receive vinorelbine IV over 5-10 minutes on days 1, 8, and 15 and oral cyclophosphamide once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses.
* Second-line therapy: Patients in any stratum with stable or progressive disease in week 9 receive 1 of 2 second-line therapy regimens.
* Regimen 1: Patients receive topotecan IV on days 1-3 and carboplatin IV on days 4 and 5 in weeks 1 and 4. Patients are then evaluated for tumor response. Patients with good response receive topotecan IV on days 1-3 and cyclophosphamide IV on days 1 and 2 in weeks 7 and 13 and etoposide IV on days 1-3 and carboplatin IV on days 4 and 5 in weeks 10 and 16. Patients with no response receive local therapy or a new chemotherapy regimen.
* Regimen 2: Patients receive doxorubicin IV on day 1 and carboplatin IV on days 1 and 2 in weeks 1 and 4. Patients are then evaluated for tumor response. Patients with good response receive doxorubicin IV on day 1 in weeks 7, 10, 13, and 16; cyclophosphamide IV on days 1 and 2 in weeks 7 and 13; and carboplatin IV on days 1 and 2 of weeks 10 and 16. Patients with no response receive local therapy or a new chemotherapy regimen.
After completion of therapy, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.
Conditions
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Sarcoma
Keywords
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alveolar childhood rhabdomyosarcoma
previously untreated childhood rhabdomyosarcoma
childhood malignant mesenchymoma
nonmetastatic childhood soft tissue sarcoma
embryonal childhood rhabdomyosarcoma
embryonal-botryoid childhood rhabdomyosarcoma
Study Design
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Allocation Method
RANDOMIZED
Primary Study Purpose
TREATMENT
Interventions
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dactinomycin
Intervention Type
BIOLOGICAL
carboplatin
Intervention Type
DRUG
cyclophosphamide
Intervention Type
DRUG
doxorubicin hydrochloride
Intervention Type
DRUG
etoposide
Intervention Type
DRUG
ifosfamide
Intervention Type
DRUG
topotecan hydrochloride
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
vinorelbine tartrate
Intervention Type
DRUG
conventional surgery
Intervention Type
PROCEDURE
radiation therapy
Intervention Type
RADIATION
Eligibility Criteria
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Inclusion 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
* 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
Maximum Eligible Age
20 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Italian Association for Pediatric Hematology Oncology
OTHER
Sponsor Role
collaborator
Children's Cancer and Leukaemia Group
OTHER
Sponsor Role
collaborator
Dutch Childhood Oncology Group
OTHER
Sponsor Role
collaborator
European Paediatric Soft Tissue Sarcoma Study Group
OTHER
Sponsor Role
lead
Principal Investigators
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Gianni Bisogno, MD
Role: STUDY_CHAIR
Azienda Ospedaliera di Padova
Meriel Jenney, MD
Role: STUDY_CHAIR
Childrens Hospital for Wales
Hans Merks, MD, PhD
Role: STUDY_CHAIR
Dutch Childhood Oncology Group
Locations
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St. Anna Children's Hospital
Vienna, , Austria
Site Status
RECRUITING
Hopital Universitaire Des Enfants Reine Fabiola
Brussels, , Belgium
Site Status
RECRUITING
Rigshospitalet - Copenhagen University Hospital
Copenhagen, , Denmark
Site Status
RECRUITING
Our Lady's Hospital for Sick Children Crumlin
Dublin, , Ireland
Site Status
RECRUITING
Vall d'Hebron University Hospital
Barcelona, , Spain
Site Status
RECRUITING
Uppsala University Hospital
Uppsala, , Sweden
Site Status
RECRUITING
University Children's Hospital
Zurich, , Switzerland
Site Status
RECRUITING
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Site Status
RECRUITING
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom
Site Status
RECRUITING
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Site Status
RECRUITING
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Site Status
RECRUITING
Leicester Royal Infirmary
Leicester, England, United Kingdom
Site Status
RECRUITING
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
Site Status
RECRUITING
Middlesex Hospital
London, England, United Kingdom
Site Status
RECRUITING
Great Ormond Street Hospital for Children
London, England, United Kingdom
Site Status
RECRUITING
Royal Manchester Children's Hospital
Manchester, England, United Kingdom
Site Status
RECRUITING
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, United Kingdom
Site Status
RECRUITING
Queen's Medical Centre
Nottingham, England, United Kingdom
Site Status
RECRUITING
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Site Status
RECRUITING
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Site Status
RECRUITING
Southampton General Hospital
Southampton, England, United Kingdom
Site Status
RECRUITING
Royal Marsden - Surrey
Sutton, England, United Kingdom
Site Status
RECRUITING
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Site Status
RECRUITING
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom
Site Status
RECRUITING
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Site Status
RECRUITING
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Site Status
RECRUITING
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom
Site Status
RECRUITING
Countries
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Austria
Belgium
Denmark
Ireland
Spain
Sweden
Switzerland
United Kingdom
Facility Contacts
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Ruth Ladenstein, MD
Role: primary
Christine Devalck, MD
Role: primary
Catherine Rechnitzer, MD, PhD
Role: primary
Fin Breatnach, MD, FRCPE
Role: primary
Soledad Gallego, MD, PhD
Role: primary
Gustaf Ljungman, MD
Role: primary
Felix Niggli, MD
Role: primary
David Hobin, MD
Role: primary
M. C. G. Stevens, MD
Role: primary
Denise Williams, MD
Role: primary
Martin Elliott, MD
Role: primary
Johann Visser, MD
Role: primary
Heather P. McDowell, MD
Role: primary
Ananth Shankar, MD
Role: primary
Julia Chisholm, MD
Role: primary
Bernadette Brennan, MD
Role: primary
Juliet Hale, MD
Role: primary
Martin Hewitt, MD, BSc, FRCP, FRCPCH
Role: primary
Sheila Lane, MD
Role: primary
Mary P. Gerrard, MBChB, FRCP, FRCPCH
Role: primary
Janice A. Kohler, MD, FRCP
Role: primary
Kathy Pritchard-Jones, MD
Role: primary
Anthony McCarthy, MD
Role: primary
Derek King, MD
Role: primary
W. Hamish Wallace, MD
Role: primary
Milind D. Ronghe, MD
Role: primary
Meriel Jenney, MD
Role: primary
References
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Orbach D, Van Noesel MM, Brennan B, Corradini N, Alaggio R, Ben Arush M, Schoot RA, Berlanga P, Zanetti I, Hjalgrim LL, Di Corti F, Ramirez G, Casanova M, Ferrari A. Epithelioid hemangioendothelioma in children: The European Pediatric Soft Tissue Sarcoma Study Group experience. Pediatr Blood Cancer. 2022 Oct;69(10):e29882. doi: 10.1002/pbc.29882. Epub 2022 Jul 16.
Reference Type
DERIVED
Schoot RA, Chisholm JC, Casanova M, Minard-Colin V, Geoerger B, Cameron AL, Coppadoro B, Zanetti I, Orbach D, Kelsey A, Rogers T, Guizani C, Elze M, Ben-Arush M, McHugh K, van Rijn RR, Ferman S, Gallego S, Ferrari A, Jenney M, Bisogno G, Merks JHM. Metastatic Rhabdomyosarcoma: Results of the European Paediatric Soft Tissue Sarcoma Study Group MTS 2008 Study and Pooled Analysis With the Concurrent BERNIE Study. J Clin Oncol. 2022 Nov 10;40(32):3730-3740. doi: 10.1200/JCO.21.02981. Epub 2022 Jun 16.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDR0000508635
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20639
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2005-000217-35
Identifier Type: -
Identifier Source: secondary_id
UKCCSG-RMS-2005
Identifier Type: -
Identifier Source: secondary_id
CCLG-EPSSG-RMS-2005
Identifier Type: -
Identifier Source: org_study_id