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NCT00002791 · CITED IN SOURCE DOCUMENTS

Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Soft Tissue Sarcoma

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

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2014-01-24

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed by surgery in treating patients who have soft tissue sarcoma.

Open the original ClinicalTrials.gov record → · Download preserved record

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 soft tissue sarcoma of an extremity or the body wall that is a primary or a postoperatively recurrent tumor Biopsy required within 2 months prior to entry Grade II or III tumor, including AJCC stages IIB and IIIB lesions at least 8 cm in diameter No more than 4 chest lesions that are no greater than 3 mm in diameter on preoperative CT The following histologies are excluded: Angiosarcoma of the scalp or face Chondrosarcoma Extraosseous Ewing's sarcoma Head and neck sarcoma Kaposi's sarcoma Osteosarcoma Primitive neuroectodermal tumor Rhabdomyosarcoma Patients on this study are also eligible for Frozen Tumor Repository study (protocol RTOG-9308) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80%-100% Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 50 U Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No congestive heart failure (CHF) within 6 months No myocardial infarction (MI) within 6 months No New York Heart Association class II-IV heart disease Left ventricular ejection fraction at least 50% by MUGA or echocardiogram If history of CHF or MI, criterion must be met within past 6 months Other: No contraindication to surgery No uncontrolled bacterial, viral, or fungal infection No serious medical or psychiatric illness that precludes informed consent or limits survival to less than 2 years No second malignancy within 5 years except: Surgically treated in situ cervical cancer Nonmelanomatous skin cancer Not pregnant or nursing Negative pregnancy test required of fertile women within 7 days prior to entry Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    filgrastim
    type
    BIOLOGICAL
  2. name
    dacarbazine
    type
    DRUG
  3. name
    doxorubicin hydrochloride
    type
    DRUG
  4. name
    ifosfamide
    type
    DRUG
  5. name
    mesna
    type
    DRUG
  6. name
    conventional surgery
    type
    PROCEDURE
  7. name
    brachytherapy
    type
    RADIATION
  8. name
    intraoperative radiation therapy
    type
    RADIATION
  9. name
    radioisotope therapy
    type
    RADIATION
Study design
primary Purpose
TREATMENT
EnrollmentSource null
Registered outcome plans (not posted results)
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed by surgery in treating patients who have soft tissue sarcoma.
detailed Description
OBJECTIVES: I. Assess whether patients with high-grade soft tissue sarcoma (STS) treated with neoadjuvant mesna/doxorubicin/ifosfamide/dacarbazine (MAID) plus radiotherapy in a cooperative group setting exhibit a response rate, toxicity, and complication rate comparable to those seen in pilot data collected by the Massachusetts General Hospital. II. Assess local control and local complications related to surgery and neoadjuvant MAID plus radiotherapy in these patients. III. Develop a tissue repository of frozen STS for ancillary genetic and flow cytometric analysis of these tumors. IV. Form an Intergroup Working Sarcoma Group that will develop a patient base, relationships, and support for the future development and completion of a phase III study of adjuvant therapy for STS. OUTLINE: The following acronyms are used: DOX Doxorubicin, NSC-123127 DTIC Dacarbazine, NSC-45388 EBRT External-Beam Radiotherapy (equipment unspecified) G-CSF Filgrastim; Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 IFF Ifosfamide, NSC-109724 MAID Mesna/DOX/IFF/DTIC Mesna Mercaptoethane sulfonate, NSC-113891 3-Drug Combination Chemotherapy plus Radiotherapy followed by Surgery followed, if indicated, by Radiotherapy followed by 3-Drug Combination Chemotherapy. MAID; plus EBRT to the primary tumor and suspected microscopic disease; followed by minimal wide surgical excision; followed, if positive margins, by postoperative EBRT; followed by MAID. PROJECTED ACCRUAL: There will be 60 patients accrued into this study within 15 months.
Source references
references
  1. citation
    Kraybill WG, Harris J, Spiro IJ, Ettinger DS, DeLaney TF, Blum RH, Lucas DR, Harmon DC, Letson GD, Eisenberg B. Long-term results of a phase 2 study of neoadjuvant chemotherapy and radiotherapy in the management of high-risk, high-grade, soft tissue sarcomas of the extremities and body wall: Radiation Therapy Oncology Group Trial 9514. Cancer. 2010 Oct 1;116(19):4613-21. doi: 10.1002/cncr.25350.
    pmid
    20572040
    type
    RESULT
  2. citation
    Kraybill WG, Harris J, Spiro IJ, Ettinger DS, DeLaney TF, Blum RH, Lucas DR, Harmon DC, Letson GD, Eisenberg B; Radiation Therapy Oncology Group Trial 9514. Phase II study of neoadjuvant chemotherapy and radiation therapy in the management of high-risk, high-grade, soft tissue sarcomas of the extremities and body wall: Radiation Therapy Oncology Group Trial 9514. J Clin Oncol. 2006 Feb 1;24(4):619-25. doi: 10.1200/JCO.2005.02.5577.
    pmid
    16446334
    type
    RESULT
  3. citation
    Kraybill WG, Spiro I, Harris J, et al.: Radiation Therapy Oncology Group (RTOG) 95-14: a phase II study of neoadjuvant chemotherapy (CT) and radiation therapy (RT) in high risk (HR), high grade, soft tissue sarcomas (STS) of the extremities and body wall: a preliminary report. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1387, 2001.
    type
    RESULT
  4. citation
    Wang D, Harris J, Kraybill WG, Eisenberg B, Kirsch DG, Ettinger DS, Kane JM 3rd, Barry PN, Naghavi A, Freeman CR, Chen YL, Hitchcock YJ, Bedi M, Salerno KE, Severin D, Godette KD, Larrier NA, Curran WJ Jr, Torres-Saavedra PA, Lucas DR. Pathologic Complete Response and Clinical Outcomes in Patients With Localized Soft Tissue Sarcoma Treated With Neoadjuvant Chemoradiotherapy or Radiotherapy: The NRG/RTOG 9514 and 0630 Nonrandomized Clinical Trials. JAMA Oncol. 2023 May 1;9(5):646-655. doi: 10.1001/jamaoncol.2023.0042.
    pmid
    36995690
    type
    DERIVED
  5. citation
    Kane JM 3rd, Magliocco A, Zhang Q, Wang D, Klimowicz A, Harris J, Simko J, DeLaney T, Kraybill W, Kirsch DG. Correlation of High-Risk Soft Tissue Sarcoma Biomarker Expression Patterns with Outcome following Neoadjuvant Chemoradiation. Sarcoma. 2018 Feb 28;2018:8310950. doi: 10.1155/2018/8310950. eCollection 2018.
    pmid
    29681762
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      source update dates
      1. context
        Updated: February 21, 2025
        datetime
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        display
        February 21, 2025

    Preserved source evidence · Not medical advice