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NCT00334854 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
UNKNOWN
Registry last update
2013-08-12

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.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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
healthy Volunteers
false
maximum Age
20 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
interventions
  1. name
    doxorubicin hydrochloride
    type
    DRUG
  2. name
    ifosfamide
    type
    DRUG
  3. name
    adjuvant therapy
    type
    PROCEDURE
  4. name
    conventional surgery
    type
    PROCEDURE
  5. name
    neoadjuvant therapy
    type
    PROCEDURE
  6. name
    radiation therapy
    type
    RADIATION
Study design
allocation
NON_RANDOMIZED
primary Purpose
TREATMENT
Enrollment
count
250
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Event-free survival
  2. measure
    Local relapse-free survival
  3. measure
    Metastases-free survival
  4. measure
    Overall survival
  5. measure
    Response rate (complete response, very good partial response [PR], PR, minor PR, and stable disease)
Full 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.
Source references
Source notices and limitations
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        <p id="_2582" tabindex="-1">Evidence (surgery):</p> <div class="pdq-content-list"><ol id="_2583"><li>The EpSSG prospective <a href="/clinicaltrials/NCT00334854">NRSTS 2005 (NCT00334854)</a> trial identified 46 patients with dermatofibrosarcoma protuberans.[<a href="#cit/section_8.45">45</a>] The median age at diagnosi
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        "-1">Evidence (surgery):</p> <div class="pdq-content-list"><ol id="_2583"><li>The EpSSG prospective <a href="/clinicaltrials/NCT00334854">NRSTS 2005 (NCT00334854)</a> trial identified 46 patients with dermatofibrosarcoma protuberans.[<a href="#cit/section_8.45">45</a>] The median age at diagnosis was 6.9 years (range, 0
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        </div></li><li>The EpSSG performed a prospective study of patients younger than 21 years with synovial sarcoma (CCLG-EPSSG-NRSTS-2005 [<a href="/clinicaltrials/NCT00334854">NCT00334854</a>]).[<a href="#cit/section_14.44">44</a>][<a href="/Common/PopUps/popDefinition.aspx?id=810035&amp;version=HealthProfessional&amp;language=Engli
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        i>The EpSSG performed a prospective study of patients younger than 21 years with synovial sarcoma (CCLG-EPSSG-NRSTS-2005 [<a href="/clinicaltrials/NCT00334854">NCT00334854</a>]).[<a href="#cit/section_14.44">44</a>][<a href="/Common/PopUps/popDefinition.aspx?id=810035&amp;version=HealthProfessional&amp;language=English" onclick="
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      source update dates
      1. context
        Updated: April 21, 2025
        datetime
        2025-04-21T12:00:00Z
        display
        April 21, 2025

    Preserved source evidence · Not medical advice