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Ifosfamide and Doxorubicin, Radiation Therapy, and/or Surgery in Treating Young Patients With Localized Soft Tissue Sarcoma

Primary Purpose

Childhood Malignant Fibrous Histiocytoma of Bone, Sarcoma

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
doxorubicin hydrochloride
ifosfamide
adjuvant therapy
conventional surgery
neoadjuvant therapy
radiation therapy
Sponsored by
European Paediatric Soft Tissue Sarcoma Study Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Malignant Fibrous Histiocytoma of Bone focused on measuring 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

Eligibility Criteria

undefined - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Anna Children's HospitalRecruiting
  • Clinique de l'EsperanceRecruiting
  • Rigshospitalet - Copenhagen University HospitalRecruiting
  • Institut Curie HopitalRecruiting
  • Our Lady's Hospital for Sick Children CrumlinRecruiting
  • Vall d'Hebron University HospitalRecruiting
  • Uppsala University HospitalRecruiting
  • University Children's HospitalRecruiting
  • Birmingham Children's HospitalRecruiting
  • Institute of Child Health at University of BristolRecruiting
  • Addenbrooke's HospitalRecruiting
  • Leeds Cancer Centre at St. James's University HospitalRecruiting
  • Leicester Royal InfirmaryRecruiting
  • Royal Liverpool Children's Hospital, Alder HeyRecruiting
  • Middlesex HospitalRecruiting
  • Great Ormond Street Hospital for ChildrenRecruiting
  • Royal Manchester Children's HospitalRecruiting
  • Sir James Spence Institute of Child Health at Royal Victoria InfirmaryRecruiting
  • Queen's Medical CentreRecruiting
  • Oxford Radcliffe HospitalRecruiting
  • Children's Hospital - SheffieldRecruiting
  • Southampton General HospitalRecruiting
  • Royal Marsden - SurreyRecruiting
  • Royal Belfast Hospital for Sick ChildrenRecruiting
  • Royal Aberdeen Children's HospitalRecruiting
  • Royal Hospital for Sick ChildrenRecruiting
  • Royal Hospital for Sick ChildrenRecruiting
  • Childrens Hospital for WalesRecruiting

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
June 7, 2006
Last Updated
August 9, 2013
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
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1. Study Identification

Unique Protocol Identification Number
NCT00334854
Brief Title
Ifosfamide and Doxorubicin, Radiation Therapy, and/or Surgery in Treating Young Patients With Localized Soft Tissue Sarcoma
Official Title
Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Malignant Fibrous Histiocytoma of Bone, Sarcoma
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Event-free survival
Title
Local relapse-free survival
Title
Metastases-free survival
Title
Overall survival
Title
Response rate (complete response, very good partial response [PR], PR, minor PR, and stable disease)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Ferrari, MD
Organizational Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Modesto Carli, MD
Organizational Affiliation
Azienda Ospedaliera di Padova
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Joern Treuner, MD
Organizational Affiliation
Olgahospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bernadette Brennan, MD
Organizational Affiliation
Royal Manchester Children's Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Max Van Noesel, MD, PhD
Organizational Affiliation
Erasmus MC - Sophia Children's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
St. Anna Children's Hospital
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Ladenstein, MD
Phone
43-1-404-700
Facility Name
Clinique de l'Esperance
City
Montegnee
ZIP/Postal Code
4420
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadine Francotte, MD
Phone
32-4-224-9111
Email
nadine.francotte@chc.be
Facility Name
Rigshospitalet - Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Rechnitzer, MD, PhD
Phone
45-3545-1368
Email
rechnitzer@rh.dk
Facility Name
Institut Curie Hopital
City
Paris
ZIP/Postal Code
75248
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Orbach, MD
Phone
33-14-432-4550
Facility Name
Our Lady's Hospital for Sick Children Crumlin
City
Dublin
ZIP/Postal Code
12
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne O'Meara, MD
Phone
353-409-6659
Facility Name
Vall d'Hebron University Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soledad Gallego, MD, PhD
Phone
34-93-489-3090
Email
sgallego@vhebron.net
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
SE-75185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustaf Ljungman, MD
Phone
46-18-611-5586
Facility Name
University Children's Hospital
City
Zurich
ZIP/Postal Code
CH-8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Niggli, MD
Phone
41-44-266-7823
Facility Name
Birmingham Children's Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B16 8ET
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Hobin, MD
Phone
44-121-454-4851
Facility Name
Institute of Child Health at University of Bristol
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8AE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. C. G. Stevens, MD
Phone
44-117-342-0205
Email
m.stevens@bristol.ac.uk
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Williams, MD
Phone
44-1223-256-298
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Glaser, MD
Phone
44-113-206-4984
Email
adam.glaser@leedsth.nhs.uk
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johann Visser, MD
Phone
44-116-258-5309
Email
johannes.visser@uhl-tr.nhs.uk
Facility Name
Royal Liverpool Children's Hospital, Alder Hey
City
Liverpool
State/Province
England
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather P. McDowell, MD
Phone
44-151-293-3679
Facility Name
Middlesex Hospital
City
London
State/Province
England
ZIP/Postal Code
W1T 3AA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ananth Shankar, MD
Phone
44-20-7380-9300 ext. 9950
Facility Name
Great Ormond Street Hospital for Children
City
London
State/Province
England
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Chisholm, MD
Phone
44-20-7829-7924
Facility Name
Royal Manchester Children's Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M27 4HA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernadette Brennan, MD
Phone
44-161-922-2227
Email
bernadette.brennan@cmmc.nhs.uk
Facility Name
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliet Hale, MD
Phone
44-191-282-4101
Email
j.p.hale@ncl.ac.uk
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Hewitt, MD, BSc, FRCP, FRCPCH
Phone
44-115-924-9924 ext. 63394
Email
martin.hewitt@nuh.nhs.uk
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Wheeler, MD
Phone
44-186-522-1066
Facility Name
Children's Hospital - Sheffield
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary P. Gerrard, MBChB, FRCP, FRCPCH
Phone
44-114-271-7366
Email
mary.gerrard@sch.nhs.uk
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janice A. Kohler, MD, FRCP
Phone
44-23-8079-6942
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Pritchard-Jones, MD
Phone
44-20-8661-3452 ext 3498
Facility Name
Royal Belfast Hospital for Sick Children
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony McCarthy, MD
Phone
44-289-063-3631
Email
anthonymcarthy@royalhospital.n.i.nhs.uk
Facility Name
Royal Aberdeen Children's Hospital
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derek King, MD
Phone
44-1224-681-818
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH9 1LF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
W. Hamish Wallace, MD
Phone
44-131-536-0426
Facility Name
Royal Hospital for Sick Children
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milind D. Ronghe, MD
Phone
44-141-201-9309
Facility Name
Childrens Hospital for Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Traunecker, MD, PhD
Phone
44-29-2074-2285
Email
heidi.traunecker@cardiffandvale.wales.nhs.uk

12. IPD Sharing Statement

Learn more about this trial

Ifosfamide and Doxorubicin, Radiation Therapy, and/or Surgery in Treating Young Patients With Localized Soft Tissue Sarcoma

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