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Phase III Study of Ifosfamide and Doxorubicin Hydrochloride, Radiotherapy, and/or Surgery in Patients With Localized Non-Rhabdomyosarcoma Soft Tissue Sarcoma
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Ifosfamide and Doxorubicin, Radiation Therapy, and/or Surgery in Treating Young Patients With Localized Soft Tissue Sarcoma
Basic Trial Information
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Protocol IDs
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Phase III
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Treatment
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Active
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Under 21
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Other
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CCLG-EPSSG-NRSTS-2005
EU-20620, EUDRACT-2005-001139-31, UKCCSG-CTA-21275/0215/001/0001, CCLG-EpSSG-STS-2006-03, NCT00334854
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Objectives Primary - Determine survival rates (event-free survival and overall survival [OS]) and the pattern of treatment failure in patients with synovial sarcoma or adult-type soft tissue sarcoma treated with ifosfamide and doxorubicin hydrochloride, radiotherapy, and/or surgery.
- Determine the role of ifosfamide and doxorubicin hydrochloride in improving the response rate in patients with unresectable synovial sarcoma or adult-type soft tissue sarcoma.
Secondary - Evaluate clinical/pathological prognostic factors, particularly tumor grade and radiological and pathological response to neoadjuvant treatment.
- Determine the impact of omitting adjuvant chemotherapy in patients with low-risk synovial sarcoma (tumor < 5 cm).
- Determine the role of adjuvant chemotherapy in improving the metastases-free survival and OS in patients with adult-type soft tissue sarcoma (Intergroup Rhabdomyosarcoma Study [IRS] postsurgical grouping system I-II, tumor grade 3, tumor size > 5 cm).
Entry Criteria Disease Characteristics:
- Histologically confirmed synovial sarcoma or adult-type soft-tissue sarcoma
- Adult-type soft tissue sarcoma includes any of the following:
- Fibrosarcoma (adult-type)
- No infantile fibrosarcoma
- Malignant peripheral nerve sheath tumor
- Malignant schwannoma
- Neurofibrosarcoma
- Epithelioid sarcoma
- Leiomyosarcoma
- Clear cell sarcoma
- Liposarcoma
- Alveolar soft-part sarcoma
- Malignant fibrous histiocytoma
- Hemangiopericytoma
- Angiosarcoma
- Dermatofibrosarcoma protuberans
- Mesenchymal chondrosarcoma
- No borderline tumors (e.g., hemangioendothelioma)
- No small round cell tumors (e.g., extraosseous Ewing's sarcoma/primitive neuroectodermal tumor or desmoplastic small round cell tumor)
- Post-irradiation soft-part sarcomas allowed
- Diagnostic surgery performed within the past 8 weeks (for patients who require adjuvant chemotherapy)
- No evidence of metastatic disease
- Involved locoregional lymph nodes are allowed
Prior/Concurrent Therapy:
- No prior cancer treatment except primary surgery
Patient Characteristics:
- No prior malignancy
- No pre-existing illness precluding study treatment*
- Normal renal function (nephrotoxicity grade 0-1)*
- No history of cardiac disease*
- Normal shortening fraction (> 28%)*
- Ejection fraction > 47%*
[Note: * For patients who require adjuvant chemotherapy] Expected Enrollment 250A total of 250 patients will be accrued for this study. Outcomes Primary Outcome(s)Event-free survival
Local relapse-free survival
Metastases-free survival
Overall survival
Response rate (complete response, very good partial response [PR], PR, minor PR, and stable disease)
Outline This is a nonrandomized, prospective, historically controlled, multicenter study. Patients with synovial sarcoma are stratified according to the Intergroup Rhabdomyosarcoma Study (IRS) postsurgical grouping system (I vs II vs III) and tumor size ( ≤ 5 cm vs > 5 cm). Patients with adult-type soft tissue sarcoma are stratified according to the IRS postsurgical grouping system (I vs II vs III), tumor size ( ≤ 5 cm vs > 5 cm), and tumor grade (G1 vs G2 vs G3). Patients are assigned to 1 of 9 treatment groups according to disease and stratification. Synovial sarcoma [Note: * Patients undergo surgery 5 weeks after completion of chemotherapy and/or radiotherapy.] [Note: **Patients undergo radiotherapy beginning < 21 days after surgery.] Adult-type soft tissue sarcoma - Group 1 (IRS group I, tumor ≤ 5 cm): Patients undergo surgical resection of tumor.
- Group 2 (IRS group I, tumor > 5 cm): Patients receive therapy according to tumor grade:
- G1 disease: Patients undergo surgical resection.
- G2 disease: Patients undergo radiotherapy 5 days a week for 5-6 weeks.
- G3 disease: Patients receive the following sequential treatment: 3 courses of IFO-DOX followed by 2 courses of ifosfamide with concurrent radiotherapy followed by 1 course of IFO-DOX.
- Group 3 (IRS group II, N0): Patients receive therapy according to tumor grade:
- G1 disease: Patients undergo surgical resection.
- G2-3 disease (≤ 5 cm) and G2 disease (> 5 cm): Patients undergo radiotherapy 5 days a week for 5-6 weeks.
- G3 disease (> 5 cm): Patients undergo sequential treatment (as in group 2, adult-type soft tissue sarcoma).
- Group 4 (IRS group III, N1): Patients receive 3 courses of IFO-DOX. Patients with no response to chemotherapy receive local therapy (as in group 5 synovial sarcoma). Patients with major or minor response to chemotherapy receive 2 courses of ifosfamide with concurrent radiotherapy followed by 2 additional courses of IFO-DOX (as in group 4, synovial sarcoma).
After completion of study therapy, patients are followed periodically for up to 10 years.
Trial Contact Information
Trial Lead Organizations European Paediatric Soft Tissue Sarcoma Study Group | | | | Andrea Ferrari, MD, Protocol chair | | | |
Associazone Italiana Ematologia Oncologia Pediatrica | | | | Modesto Carli, MD, Protocol chair | | | |
Cooperative Weichteilsarkom Studie | | | | Joern Treuner, MD, Protocol chair | | | |
Children's Cancer and Leukaemia Group | | | | Bernadette Brennan, MD, Protocol chair | | | |
Dutch Childhood Oncology Group | | | | Max Van Noesel, MD, PhD, Protocol chair | | | |
Trial Sites
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| Austria |
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Vienna |
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| | | | St. Anna Children's Hospital |
| | | Ruth Ladenstein, MD | |
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| Belgium |
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Montegnee |
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| | | | Clinique de l'Esperance |
| | | Nadine Francotte, MD | |
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nadine.francotte@chc.be |
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| Denmark |
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Copenhagen |
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| | | | Rigshospitalet - Copenhagen University Hospital |
| | | Catherine Rechnitzer, MD, PhD | |
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rechnitzer@rh.dk |
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| France |
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Paris |
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| | | | Institut Curie Hopital |
| | | Daniel Orbach, MD | |
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| Germany |
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Stuttgart |
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| | | | Olgahospital |
| | | Ewa Koscielniak, MD | |
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| Ireland |
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Dublin |
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| | | | Our Lady's Hospital for Sick Children Crumlin |
| | | Fin Breatnach, MD, FRCPE | |
| | Email:
fin.breatnach@olhsc.ie |
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| Spain |
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Barcelona |
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| | | | Vall d'Hebron University Hospital |
| | | Soledad Gallego, MD, PhD | |
| | Email:
sgallego@vhebron.net |
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| Sweden |
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Uppsala |
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| | | | Uppsala University Hospital |
| | | Gustaf Ljungman, MD | |
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| Switzerland |
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Zurich |
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| | | | University Children's Hospital |
| | | Felix Niggli, MD | |
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| United Kingdom |
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| England |
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Birmingham |
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| | | | | Birmingham Children's Hospital |
| | | Martin English, MD | |
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martin.english@bch.nhs.uk |
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Bristol |
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| | | Institute of Child Health at University of Bristol |
| | | Pamela Kearns, MD | |
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Cambridge |
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| | | Addenbrooke's Hospital |
| | | Amos Burke, MD | |
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Leeds |
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| | | Leeds Cancer Centre at St. James's University Hospital |
| | | Adam Glaser, MD | |
| | Email:
adam.glaser@leedsth.nhs.uk |
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Leicester |
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| | | Leicester Royal Infirmary |
| | | Johann Visser, MD | |
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johannes.visser@uhl-tr.nhs.uk |
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Liverpool |
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| | | Royal Liverpool Children's Hospital, Alder Hey |
| | | Heather McDowell, MD | |
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London |
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| | | Great Ormond Street Hospital for Children |
| | | Gill Levitt, MD | | Ph: | 44-20-7405-9200 ext. 0073 | | |
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| | | Middlesex Hospital |
| | | Ananth Shankar, MD | | Ph: | 44-20-7380-9300 ext. 9950 | | |
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Manchester |
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| | | Royal Manchester Children's Hospital |
| | | Bernadette Brennan, MD | |
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bernadette.brennan@cmmc.nhs.uk |
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Newcastle-Upon-Tyne |
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| | | Sir James Spence Institute of Child Health at Royal Victoria Infirmary |
| | | Juliet Hale, MD | |
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j.p.hale@ncl.ac.uk |
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Nottingham |
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| | | Queen's Medical Centre |
| | | Martin Hewitt, MD, BSc, FRCP, FRCPCH | | Ph: | 44-115-924-9924 ext. 63394 | | |
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martin.hewitt@nuh.nhs.uk |
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Oxford |
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| | | Oxford Radcliffe Hospital |
| | | Kate Wheeler, MD | |
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Sheffield |
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| | | Children's Hospital - Sheffield |
| | | Mary Gerrard, BSc, MBChB, FRCP, FRCPCH | |
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mary.gerrard@sch.nhs.uk |
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Southampton |
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| | | Southampton General Hospital |
| | | Janice Kohler, MD, FRCP | |
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Sutton |
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| | | Royal Marsden - Surrey |
| | | Mary Taj, MD | | Ph: | 44-20-8642-6011 ext. 3089 | | |
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| Northern Ireland |
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Belfast |
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| | | | Royal Belfast Hospital for Sick Children |
| | | Anthony McCarthy, MD | |
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anthonymcarthy@royalhospital.n.i.nhs.uk |
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| Scotland |
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Aberdeen |
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| | | | Royal Aberdeen Children's Hospital |
| | | Veronica Neefjes | |
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Edinburgh |
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| | | Royal Hospital for Sick Children |
| | | W. Hamish Wallace, MD | |
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Glasgow |
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| | | Royal Hospital for Sick Children |
| | | Milind Ronghe, MD | |
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| Wales |
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Cardiff |
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| | | | Childrens Hospital for Wales |
| | | Heidi Traunecker, MD, PhD | |
| | Email:
heidi.traunecker@cardiffandvale.wales.nhs.uk |
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| Registry Information | | | Official Title | | Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas | | | Trial Start Date | | 2006-03-01 | | | Trial Completion Date | | 2010-05-31 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00334854 | | | Date Submitted to PDQ | | 2006-04-18 | | | Information Last Verified | | 2008-04-27 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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