Childhood Malignant Fibrous Histiocytoma of BonePhase 3NCT00334854
Ifosfamide and Doxorubicin, Radiation Therapy, and/or Surgery in Treating Young Patients With Localized Soft Tissue Sarcoma
A Phase 3 study testing doxorubicin hydrochloride, ifosfamide and adjuvant therapy in people with Childhood Malignant Fibrous Histiocytoma of Bone and Sarcoma, run by European Paediatric Soft Tissue Sarcoma Study Group at 28 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Childhood Malignant Fibrous Histiocytoma of Bone, Sarcoma
- What is being tested?
- doxorubicin hydrochloride, ifosfamide and adjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 28 sitesin 9 countries
- Study dates
- Mar 2006to May 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
28 sites in 9 countries.
28 sites in 9 countries
United Kingdom20 sites, 20 recruiting
- Recruiting
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, AB25 2ZG
Derek King, MD, 44-1224-681-818
- Recruiting
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE
Anthony McCarthy, MD, 44-289-063-3631, anthonymcarthy@royalhospital.n.i.nhs.uk
- Recruiting
Birmingham Children's Hospital
Birmingham, England, B16 8ET
David Hobin, MD, 44-121-454-4851
- Recruiting
Institute of Child Health at University of Bristol
Bristol, England, BS2 8AE
M. C. G. Stevens, MD, 44-117-342-0205, m.stevens@bristol.ac.uk
- Recruiting
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Denise Williams, MD, 44-1223-256-298
- Recruiting
Childrens Hospital for Wales
Cardiff, Wales, CF14 4XW
Heidi Traunecker, MD, PhD, 44-29-2074-2285, heidi.traunecker@cardiffandvale.wales.nhs.uk
- Recruiting
Royal Hospital for Sick Children
Edinburgh, Scotland, EH9 1LF
W. Hamish Wallace, MD, 44-131-536-0426
- Recruiting
Royal Hospital for Sick Children
Glasgow, Scotland, G3 8SJ
Milind D. Ronghe, MD, 44-141-201-9309
- Recruiting
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Adam Glaser, MD, 44-113-206-4984, adam.glaser@leedsth.nhs.uk
- Recruiting
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Johann Visser, MD, 44-116-258-5309, johannes.visser@uhl-tr.nhs.uk
- Recruiting
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, L12 2AP
Heather P. McDowell, MD, 44-151-293-3679
- Recruiting
Middlesex Hospital
London, England, W1T 3AA
Ananth Shankar, MD, 44-20-7380-9300 ext. 9950
- Recruiting
Great Ormond Street Hospital for Children
London, England, WC1N 3JH
Julia Chisholm, MD, 44-20-7829-7924
- Recruiting
Royal Manchester Children's Hospital
Manchester, England, M27 4HA
Bernadette Brennan, MD, 44-161-922-2227, bernadette.brennan@cmmc.nhs.uk
- Recruiting
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, NE1 4LP
Juliet Hale, MD, 44-191-282-4101, j.p.hale@ncl.ac.uk
- Recruiting
Queen's Medical Centre
Nottingham, England, NG7 2UH
Martin Hewitt, MD, BSc, FRCP, FRCPCH, 44-115-924-9924 ext. 63394, martin.hewitt@nuh.nhs.uk
- Recruiting
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
Kate Wheeler, MD, 44-186-522-1066
- Recruiting
Children's Hospital - Sheffield
Sheffield, England, S10 2TH
Mary P. Gerrard, MBChB, FRCP, FRCPCH, 44-114-271-7366, mary.gerrard@sch.nhs.uk
- Recruiting
Southampton General Hospital
Southampton, England, SO16 6YD
Janice A. Kohler, MD, FRCP, 44-23-8079-6942
- Recruiting
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Kathy Pritchard-Jones, MD, 44-20-8661-3452 ext 3498
Austria1 site, 1 recruiting
- Recruiting
St. Anna Children's Hospital
Vienna, A-1090
Ruth Ladenstein, MD, 43-1-404-700
Belgium1 site, 1 recruiting
- Recruiting
Clinique de l'Esperance
Montegnée, 4420
Nadine Francotte, MD, 32-4-224-9111, nadine.francotte@chc.be
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet - Copenhagen University Hospital
Copenhagen, 2100
Catherine Rechnitzer, MD, PhD, 45-3545-1368, rechnitzer@rh.dk
France1 site, 1 recruiting
- Recruiting
Institut Curie Hopital
Paris, 75248
Daniel Orbach, MD, 33-14-432-4550
Ireland1 site, 1 recruiting
- Recruiting
Our Lady's Hospital for Sick Children Crumlin
Dublin, 12
Anne O'Meara, MD, 353-409-6659
Spain1 site, 1 recruiting
- Recruiting
Vall d'Hebron University Hospital
Barcelona, 08035
Soledad Gallego, MD, PhD, 34-93-489-3090, sgallego@vhebron.net
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala, SE-75185
Gustaf Ljungman, MD, 46-18-611-5586
Switzerland1 site, 1 recruiting
- Recruiting
University Children's Hospital
Zurich, CH-8032
Felix Niggli, MD, 41-44-266-7823
About this study
Official title: Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas
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.
Read the detailed description
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).
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
- Group 1 (IRS group I, tumor ≤ 5 cm): Patients undergo surgical resection of tumor.
- Group 2 (IRS group I, tumor > 5 cm): Patients receive ifosfamide IV over 3 hours on days 1-3 and doxorubicin hydrochloride IV over 4-6 hours on days 1 and 2 (IFO-DOX). Treatment repeats every 21 days for 4 courses.
- Group 3 (IRS group II, tumor ≤ 5 cm): Patients receive 3 courses of IFO-DOX. After the completion of chemotherapy, patients undergo radiotherapy 5 days a week for 5-6 weeks.
- Group 4 (IRS group II, tumor > 5 cm): Patients receive 3 courses of IFO-DOX. Patients then receive ifosfamide alone IV over 3 hours on days 1-3. Treatment with ifosfamide repeats every 21 days for 2 courses. Patients also receive concurrent radiotherapy (concurrently with ifosfamide) 5 days a week for 5-6 weeks. After completion of radiotherapy, patients receive 1 additional course of IFO-DOX.
- Group 5 (IRS group III, N1): Patients receive 3 courses of IFO-DOX. Patients with no response to chemotherapy receive 1 of the following local therapies:
- Delayed complete resection*
- Radiotherapy (as in group 3) followed by surgery*
- Delayed complete resection* followed by radiotherapy** (as in group 3)
- Delayed incomplete resection* followed by radiotherapy** (as in group 3)
- Radiotherapy (as in group 3) Patients with major or minor response to chemotherapy receive 2 courses of ifosfamide with concurrent radiotherapy followed by 1 additional course of IFO-DOX (as in group 4, above).
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.
PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study.
- Being tested
- doxorubicin hydrochloride, ifosfamide, adjuvant therapy, conventional surgery, neoadjuvant therapy
- Keywords
- 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
- Medical subject headings
- Sarcoma, Hemangiosarcoma, Fibrosarcoma, Liposarcoma, Hemangiopericytoma, Malignant, Dermatofibrosarcoma, Chondrosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ifosfamideDrug
adjuvant therapyProcedure or surgery
conventional surgeryProcedure or surgery
neoadjuvant therapyProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startMar 2006
- Primary completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Malignant Fibrous Histiocytoma of BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Paediatric Soft Tissue Sarcoma Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Italian Association for Pediatric Hematology Oncology, Cooperative Weichteilsarkom Studie, Children's Cancer and Leukaemia Group, Dutch Childhood Oncology Group
- Investigators
- Andrea Ferrari, MD, Study chair, Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoModesto Carli, MD, Study chair, Azienda Ospedaliera di PadovaJoern Treuner, MD, Study chair, OlgahospitalBernadette Brennan, MD, Study chair, Royal Manchester Children's HospitalMax Van Noesel, MD, PhD, Study chair, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334854
- Sponsor's protocol ID
- CCLG-EPSSG-NRSTS-2005
- Other IDs
- CDR0000482277, EU-20620, EUDRACT-2005-001139-31, UKCCSG-CTA-21275/0215/001/0001, CCLG-EpSSG-STS-2006-03
- Status last verified
- Jul 2009
- First submitted
- 7 Jun 2006
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT00334854
- Acronym / sponsor ID
- CCLG-EPSSG-NRSTS-2005
- Keywords
- childhood synovial sarcoma, nonmetastatic childhood soft tissue sarcoma, childhood alveolar soft-part sarcoma, childhood angiosarcoma, childhood epithelioid sarcoma, childhood fibrosarcoma, childhood leiomyosarcoma, childhood liposarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- European Paediatric Soft Tissue Sarcoma Study GroupUniversity, hospital or other
- Collaborators
- Italian Association for Pediatric Hematology Oncology, Cooperative Weichteilsarkom Studie, Children's Cancer and Leukaemia Group, Dutch Childhood Oncology Group
- Study start
- Mar 2006
- Primary completion
- May 2010 (estimated)
- First posted
- 8 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
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
- Group 1 (IRS group I, tumor ≤ 5 cm): Patients undergo surgical resection of tumor.
- Group 2 (IRS group I, tumor > 5 cm): Patients receive ifosfamide IV over 3 hours on days 1-3 and doxorubicin hydrochloride IV over 4-6 hours on days 1 and 2 (IFO-DOX). Treatment repeats every 21 days for 4 courses.
- Group 3 (IRS group II, tumor ≤ 5 cm): Patients receive 3 courses of IFO-DOX. After the completion of chemotherapy, patients undergo radiotherapy 5 days a week for 5-6 weeks.
- Group 4 (IRS group II, tumor > 5 cm): Patients receive 3 courses of IFO-DOX. Patients then receive ifosfamide alone IV over 3 hours on days 1-3. Treatment with ifosfamide repeats every 21 days for 2 courses. Patients also receive concurrent radiotherapy (concurrently with ifosfamide) 5 days a week for 5-6 weeks. After completion of radiotherapy, patients receive 1 additional course of IFO-DOX.
- Group 5 (IRS group III, N1): Patients receive 3 courses of IFO-DOX. Patients with no response to chemotherapy receive 1 of the following local therapies:
- Delayed complete resection*
- Radiotherapy (as in group 3) followed by surgery*
- Delayed complete resection* followed by radiotherapy** (as in group 3)
- Delayed incomplete resection* followed by radiotherapy** (as in group 3)
- Radiotherapy (as in group 3) Patients with major or minor response to chemotherapy receive 2 courses of ifosfamide with concurrent radiotherapy followed by 1 additional course of IFO-DOX (as in group 4, above).
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.
PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doxorubicin hydrochloride | Drug | – |
| ifosfamide | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| conventional surgery | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Ferrari, MD study chair
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Modesto Carli, MD study chair
Azienda Ospedaliera di Padova
Joern Treuner, MD study chair
Olgahospital
28 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing doxorubicin hydrochloride, ifosfamide and adjuvant therapy in people with Childhood Malignant Fibrous Histiocytoma of Bone and Sarcoma, run by European Paediatric Soft Tissue Sarcoma Study Group at 28 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United Kingdom, Austria, Belgium, Denmark, France and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.