Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients with Soft Tissue Sarcoma

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 07-002378
    NCT ID: NCT00346164
    Sponsor Protocol Number: ARST0332

About this study

This phase III trial is studying observation to see how well a risk based treatment strategy works in patients with soft tissue sarcoma. In the study, patients are assigned to receive surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells. 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 chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Newly diagnosed non-rhabdomyosarcoma soft tissue sarcoma (STS), confirmed by central pathology review via concurrent enrollment on protocol COG-D9902
  • Metastatic or non metastatic disease
  • Meets 1 of the following criteria
    • Intermediate (i.e., rarely metastasizing) or malignant STS, including any of the following
      • Adipocytic tumor, including liposarcoma of any of the following histology subtypes
        • Dedifferentiated
        • Myxoid
        • Round cell
        • Pleomorphic type
        • Mixed-type
        • Not otherwise specified (NOS)
      • Fibroblastic/myofibroblastic tumors, including any of the following
        • Solitary fibrous tumor
        • Hemangiopericytoma
        • Low-grade myofibroblastic sarcoma
        • Myxoinflammatory fibroblastic sarcoma
        • Adult fibrosarcoma
        • Myxofibrosarcoma
        • Low-grade fibromyxoid sarcoma or hyalinizing spindle-cell tumor
        • Sclerosing epithelioid fibrosarcoma
      • So-called fibrohistiocytic tumors, including any of the following
        • Plexiform fibrohistiocytic tumor
        • Giant cell tumor of soft tissues
        • Pleomorphic malignant fibrous histiocytoma (MFH)/undifferentiated pleomorphic sarcoma
        • Giant cell MFH/undifferentiated pleomorphic sarcoma with giant cells
        • Inflammatory MFH/undifferentiated pleomorphic sarcoma with prominent inflammation
      • Smooth muscle tumor (leiomyosarcoma)
      • Pericytic [perivascular] tumor (malignant glomus tumor or glomangiosarcoma)
      • Vascular tumor, including angiosarcoma
      • Chondro-osseous tumors of any of the following types
        • Mesenchymal chondrosarcoma
        • Extraskeletal osteosarcoma
      • Tumors of uncertain differentiation, including any of the following
        • Angiomatoid fibrous histiocytoma
        • Ossifying fibromyxoid tumor
        • Myoepithelioma/parachordoma
        • Synovial sarcoma
        • Epithelioid sarcoma
        • Alveolar soft-part sarcoma
        • Clear cell sarcoma of soft tissue
        • Extraskeletal myxoid chondrosarcoma ("chordoid type")
        • Malignant mesenchymoma
        • Neoplasms with perivascular epithelioid cell differentiation (PEComa)
        • Clear cell myomelanocytic tumor
        • Intimal sarcoma
    • Malignant peripheral nerve sheath tumor
    • Dermatofibrosarcoma protuberans meeting both of the following criteria
      • Non metastatic disease
      • Tumor must be grossly resected prior to study enrollment
    • Embryonal sarcoma of the liver
    • Unclassified STS that is too undifferentiated to be placed in a specific pathologic category (undifferentiated STS or STS NOS)
  • Gross resection of the primary tumor ≤ 42 days prior to enrollment required except if any of the following circumstances apply
    • Non metastatic high-grade tumor > 5 cm in maximal diameter and gross or microscopic residual tumor is anticipated after resection
    • Tumor of either high- or- low-grade that cannot be grossly excised without unacceptable morbidity
    • High-grade tumor with metastases
      • Patients with metastatic low-grade tumor whose disease is amenable to gross resection at all sites must undergo gross resection of all sites prior to study entry
  • Patients with a tumor recurrence after a gross total resection are not eligible
  • Tumors arising in bone are not eligible
  • Patients with epithelioid sarcoma, clear cell sarcoma, or clinical or radiologic evidence of regional lymph node enlargement must undergo sentinel lymph node biopsies or lymph node sampling to confirm the status of regional lymph nodes
    • Except in cases where the study radiologist reviews the imaging and indicates that a biopsy is not needed to confirm that the patient has lymph node involvement
      • If lymph node biopsies are positive for tumor (or the lymph nodes are classified as positive by the study radiologist), formal lymph node dissection must be done at the time of definitive surgery(prior to study entry for patients assigned to study regimen C)
  • Patients with metastatic disease must undergo a biopsy to confirm the presence of metastatic tumor if all metastases are < 1 cm in maximal diameter (except in cases where the study radiologist reviews the imaging and indicated that a biopsy is not needed to confirm that the patient has metastatic disease)
  • Lansky performance status (PS) 50-100% (for patients ≤ 16 years of age) 
  • Karnofsky PS 50-100% (for patients > 16 years of age)
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count ≥ 1,000/mm³*
  • Platelet count ≥ 100,000/mm³*
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min (≥ 40 mL/min for infants < 1 year of age)
  • serum creatinine based on age and/or gender as follows
    • 0.4 mg/dL (1 month to < 6 months of age)
    • 0.5 mg/dL (6 months to < 1 year of age)
    • 0.6 mg/dL (1 year to < 2 years of age)
    • 0.8 mg/dL (2 years to < 6 years of age)
    • 1.0 mg/dL (6 years to < 10 years of age)
    • 1.2 mg/dL (10 years to < 13 years of age)
    • 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 years to < 16 years of age)
    • 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
  • Patients with urinary tract obstruction by tumor must meet the renal function criteria listed above AND must have unimpeded urinary flow established via decompression of the obstructed portion of the urinary tract
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)*
  • Shortening fraction ≥ 27% by echocardiogram* OR ejection fraction ≥ 50% by radionuclide angiogram*
  • Not pregnant or nursing (patients undergoing radiotherapy and/or chemotherapy)
    • No nursing for ≥ 1 month after completion of study treatment in study regimens C or D
  • Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
  • Negative pregnancy test
  • No evidence of dyspnea at rest
  • No exercise intolerance
  • Resting pulse oximetry reading > 94% on room air (for patients with respiratory symptoms)
  • Prior treatment for cancer allowed provided the patient meet the prior therapy requirements
  • No prior anthracycline (e.g., doxorubicin or daunorubicin) or ifosfamide chemotherapy for patients enrolled on arm C or arm D
  • No prior radiotherapy to tumor-involved sites

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Carola A Arndt, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions