Ifosfamide and Doxorubicin, Radiation Therapy, and/or Surgery in Treating Young Patients With Localized Soft Tissue Sarcoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
European Paediatric Soft Tissue Sarcoma Study Group
Collaborators:
Italian Association for Pediatric Hematology Oncology
Cooperative Weichteilsarkom Studie
Children's Cancer and Leukaemia Group
Dutch Childhood Oncology Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00334854
First received: June 7, 2006
Last updated: August 7, 2009
Last verified: July 2009
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Purpose
RATIONALE: Drugs used in chemotherapy, such as ifosfamide and doxorubicin, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase III trial is studying how well giving ifosfamide and doxorubicin, radiation therapy, and/or surgery works in treating young patients with localized soft tissue sarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Childhood Malignant Fibrous Histiocytoma of Bone Sarcoma |
Drug: doxorubicin hydrochloride Drug: ifosfamide Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Event-free survival [ Designated as safety issue: No ]
- Local relapse-free survival [ Designated as safety issue: No ]
- Metastases-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Response rate (complete response, very good partial response [PR], PR, minor PR, and stable disease) [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | March 2006 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
PRIOR CONCURRENT THERAPY:
- No prior cancer treatment except primary surgery
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334854
Locations
| Austria | |
| St. Anna Children's Hospital | Recruiting |
| Vienna, Austria, A-1090 | |
| Contact: Ruth Ladenstein, MD 43-1-404-700 | |
| Belgium | |
| Clinique de l'Esperance | Recruiting |
| Montegnee, Belgium, 4420 | |
| Contact: Nadine Francotte, MD 32-4-224-9111 nadine.francotte@chc.be | |
| Denmark | |
| Rigshospitalet - Copenhagen University Hospital | Recruiting |
| Copenhagen, Denmark, 2100 | |
| Contact: Catherine Rechnitzer, MD, PhD 45-3545-1368 rechnitzer@rh.dk | |
| France | |
| Institut Curie Hopital | Recruiting |
| Paris, France, 75248 | |
| Contact: Daniel Orbach, MD 33-14-432-4550 | |
| Ireland | |
| Our Lady's Hospital for Sick Children Crumlin | Recruiting |
| Dublin, Ireland, 12 | |
| Contact: Anne O'Meara, MD 353-409-6659 | |
| Spain | |
| Vall d'Hebron University Hospital | Recruiting |
| Barcelona, Spain, 08035 | |
| Contact: Soledad Gallego, MD, PhD 34-93-489-3090 sgallego@vhebron.net | |
| Sweden | |
| Uppsala University Hospital | Recruiting |
| Uppsala, Sweden, SE-75185 | |
| Contact: Gustaf Ljungman, MD 46-18-611-5586 | |
| Switzerland | |
| University Children's Hospital | Recruiting |
| Zurich, Switzerland, CH-8032 | |
| Contact: Felix Niggli, MD 41-44-266-7823 | |
| United Kingdom | |
| Birmingham Children's Hospital | Recruiting |
| Birmingham, England, United Kingdom, B16 8ET | |
| Contact: David Hobin, MD 44-121-454-4851 | |
| Institute of Child Health at University of Bristol | Recruiting |
| Bristol, England, United Kingdom, BS2 8AE | |
| Contact: M. C. G. Stevens, MD 44-117-342-0205 m.stevens@bristol.ac.uk | |
| Addenbrooke's Hospital | Recruiting |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Contact: Denise Williams, MD 44-1223-256-298 | |
| Leeds Cancer Centre at St. James's University Hospital | Recruiting |
| Leeds, England, United Kingdom, LS9 7TF | |
| Contact: Adam Glaser, MD 44-113-206-4984 adam.glaser@leedsth.nhs.uk | |
| Leicester Royal Infirmary | Recruiting |
| Leicester, England, United Kingdom, LE1 5WW | |
| Contact: Johann Visser, MD 44-116-258-5309 johannes.visser@uhl-tr.nhs.uk | |
| Royal Liverpool Children's Hospital, Alder Hey | Recruiting |
| Liverpool, England, United Kingdom, L12 2AP | |
| Contact: Heather P. McDowell, MD 44-151-293-3679 | |
| Great Ormond Street Hospital for Children | Recruiting |
| London, England, United Kingdom, WC1N 3JH | |
| Contact: Julia Chisholm, MD 44-20-7829-7924 | |
| Middlesex Hospital | Recruiting |
| London, England, United Kingdom, W1T 3AA | |
| Contact: Ananth Shankar, MD 44-20-7380-9300 ext. 9950 | |
| Royal Manchester Children's Hospital | Recruiting |
| Manchester, England, United Kingdom, M27 4HA | |
| Contact: Bernadette Brennan, MD 44-161-922-2227 bernadette.brennan@cmmc.nhs.uk | |
| Sir James Spence Institute of Child Health at Royal Victoria Infirmary | Recruiting |
| Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP | |
| Contact: Juliet Hale, MD 44-191-282-4101 j.p.hale@ncl.ac.uk | |
| Queen's Medical Centre | Recruiting |
| Nottingham, England, United Kingdom, NG7 2UH | |
| Contact: Martin Hewitt, MD, BSc, FRCP, FRCPCH 44-115-924-9924 ext. 63394 martin.hewitt@nuh.nhs.uk | |
| Oxford Radcliffe Hospital | Recruiting |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Contact: Kate Wheeler, MD 44-186-522-1066 | |
| Children's Hospital - Sheffield | Recruiting |
| Sheffield, England, United Kingdom, S10 2TH | |
| Contact: Mary P. Gerrard, MBChB, FRCP, FRCPCH 44-114-271-7366 mary.gerrard@sch.nhs.uk | |
| Southampton General Hospital | Recruiting |
| Southampton, England, United Kingdom, SO16 6YD | |
| Contact: Janice A. Kohler, MD, FRCP 44-23-8079-6942 | |
| Royal Marsden - Surrey | Recruiting |
| Sutton, England, United Kingdom, SM2 5PT | |
| Contact: Kathy Pritchard-Jones, MD 44-20-8661-3452 ext 3498 | |
| Royal Belfast Hospital for Sick Children | Recruiting |
| Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
| Contact: Anthony McCarthy, MD 44-289-063-3631 anthonymcarthy@royalhospital.n.i.nhs.uk | |
| Royal Aberdeen Children's Hospital | Recruiting |
| Aberdeen, Scotland, United Kingdom, AB25 2ZG | |
| Contact: Derek King, MD 44-1224-681-818 | |
| Royal Hospital for Sick Children | Recruiting |
| Edinburgh, Scotland, United Kingdom, EH9 1LF | |
| Contact: W. Hamish Wallace, MD 44-131-536-0426 | |
| Royal Hospital for Sick Children | Recruiting |
| Glasgow, Scotland, United Kingdom, G3 8SJ | |
| Contact: Milind D. Ronghe, MD 44-141-201-9309 | |
| Childrens Hospital for Wales | Recruiting |
| Cardiff, Wales, United Kingdom, CF14 4XW | |
| Contact: Heidi Traunecker, MD, PhD 44-29-2074-2285 heidi.traunecker@cardiffandvale.wales.nhs.uk | |
Sponsors and Collaborators
European Paediatric Soft Tissue Sarcoma Study Group
Italian Association for Pediatric Hematology Oncology
Cooperative Weichteilsarkom Studie
Children's Cancer and Leukaemia Group
Dutch Childhood Oncology Group
Investigators
| Study Chair: | Andrea Ferrari, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
| Study Chair: | Modesto Carli, MD | Azienda Ospedaliera di Padova |
| Study Chair: | Joern Treuner, MD | Olgahospital |
| Study Chair: | Bernadette Brennan, MD | Royal Manchester Children's Hospital |
| Study Chair: | Max Van Noesel, MD, PhD | Erasmus MC - Sophia Children's Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00334854 History of Changes |
| Other Study ID Numbers: | CDR0000482277, CCLG-EPSSG-NRSTS-2005, EU-20620, EUDRACT-2005-001139-31, UKCCSG-CTA-21275/0215/001/0001, CCLG-EpSSG-STS-2006-03 |
| Study First Received: | June 7, 2006 |
| Last Updated: | August 7, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
childhood synovial sarcoma nonmetastatic childhood soft tissue sarcoma childhood alveolar soft-part sarcoma childhood angiosarcoma childhood epithelioid sarcoma childhood fibrosarcoma childhood leiomyosarcoma |
childhood liposarcoma childhood neurofibrosarcoma localized childhood malignant fibrous histiocytoma of bone childhood malignant hemangiopericytoma dermatofibrosarcoma protuberans chondrosarcoma |
Additional relevant MeSH terms:
|
Histiocytoma Fibrosis Histiocytoma, Benign Fibrous Histiocytoma, Malignant Fibrous Sarcoma Neoplasms, Fibrous Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Pathologic Processes |
Doxorubicin Isophosphamide mustard Ifosfamide Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 16, 2012
