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Trial record 2 of 23 for:    "Undifferentiated Pleomorphic Sarcoma" | "Antibiotics, Antitubercular"

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

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ClinicalTrials.gov Identifier: NCT00334854
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : June 8, 2006
Last Update Posted : August 12, 2013
Sponsor:
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)

Tracking Information
First Submitted Date  ICMJE June 7, 2006
First Posted Date  ICMJE June 8, 2006
Last Update Posted Date August 12, 2013
Study Start Date  ICMJE March 2006
Estimated Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2006)
  • 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)
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00334854 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ifosfamide and Doxorubicin, Radiation Therapy, and/or Surgery in Treating Young Patients With Localized Soft Tissue Sarcoma
Official Title  ICMJE Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Primary Purpose: Treatment
Condition  ICMJE
  • Childhood Malignant Fibrous Histiocytoma of Bone
  • Sarcoma
Intervention  ICMJE
  • Drug: doxorubicin hydrochloride
  • Drug: ifosfamide
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
  • Radiation: radiation therapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
250
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Denmark,   France,   Ireland,   Spain,   Sweden,   Switzerland,   United Kingdom
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT00334854
Other Study ID Numbers  ICMJE CCLG-EPSSG-NRSTS-2005
CDR0000482277 ( Registry Identifier: PDQ (Physician Data Query) )
EU-20620
EUDRACT-2005-001139-31
UKCCSG-CTA-21275/0215/001/0001
CCLG-EpSSG-STS-2006-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE European Paediatric Soft Tissue Sarcoma Study Group
Collaborators  ICMJE
  • Italian Association for Pediatric Hematology Oncology
  • Cooperative Weichteilsarkom Studie
  • Children's Cancer and Leukaemia Group
  • Dutch Childhood Oncology Group
Investigators  ICMJE
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
PRS Account National Cancer Institute (NCI)
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP