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Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2009
First Received: June 28, 2006   Last Updated: November 5, 2009   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00346164
  Purpose

RATIONALE: 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. It is not yet known which regimen is more effective in treating soft tissue sarcoma.

PURPOSE: This phase III trial is studying observation to see how well it works compared with radiation therapy, combination chemotherapy, and/or surgery in treating patients with soft tissue sarcoma.


Condition Intervention Phase
Childhood Malignant Fibrous Histiocytoma of Bone
Sarcoma
Drug: doxorubicin hydrochloride
Drug: ifosfamide
Procedure: observation
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Risk-Based Treatment for Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS) in Patients Under 30 Years of Age

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Long-term survival at 5 years [ Designated as safety issue: No ]
  • Event-free and overall survival at 5 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local tumor control at 5 years [ Designated as safety issue: No ]
  • Feasibility of neoadjuvant chemoradiotherapy [ Designated as safety issue: No ]
  • Imaging and pathologic response after neoadjuvant chemoradiotherapy, and their relationship to survival and local outcomes [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: February 2007
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1: Experimental
(Low risk [nonmetastatic, grossly resected disease, except high-grade tumor > 5 cm]): Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to receive regimen A (observation only). Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to receive regimen B (beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy).
Procedure: observation
Patients undergo observation
Radiation: radiation therapy
Patients undergo radiotherapy
Group 2: Experimental
(Intermediate risk [nonmetastatic, resected high-grade tumor > 5 cm or unresected disease]): Patients with grossly resected, high-grade tumor > 5 cm (in maximum diameter) are assigned to receive regimen C (adjuvant chemoradiotherapy) for approximately 19 weeks. Patients with unresected tumor are assigned to receive regimen D (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy) lasting approximately 25 weeks.
Drug: doxorubicin hydrochloride
Given IV
Drug: ifosfamide
Given IV
Procedure: therapeutic conventional surgery
Patients undergo surgery
Radiation: radiation therapy
Patients undergo radiotherapy
Group 3: Experimental
(High risk [metastatic, resected, incompletely resected, or unresected disease]): Patients with low-grade, all-sites resected tumor with either negative or positive microscopic margins are assigned to receive treatment as in group 1 regimen A. Patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive treatment as in group 2 regimen C. Patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in group 2 regimen D.
Drug: doxorubicin hydrochloride
Given IV
Drug: ifosfamide
Given IV
Procedure: observation
Patients undergo observation
Procedure: therapeutic conventional surgery
Patients undergo surgery
Radiation: radiation therapy
Patients undergo radiotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed non-rhabdomyosarcoma soft tissue sarcoma (STS), confirmed by central pathology review via concurrent enrollment on protocol COG-D9902

    • Metastatic or nonmetastatic 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* NOTE: *Patients < 2 years of age with infantile fibrosarcoma not allowed
        • 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:

      • Nonmetastatic 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:

    • Nonmetastatic 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
  • 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*

    • 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)
  • NOTE: *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.
  • 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)

PATIENT CHARACTERISTICS:

  • Lansky performance status (PS) 50-100% (for patients ≤ 16 years of age) OR Karnofsky PS 50-100% (for patients > 16 years of age)
  • Life expectancy ≥ 3 months
  • Hemoglobin ≥ 10 g/dL (may be supported by transfusion)*
  • 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)*
  • 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

    • 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
  • No evidence of dyspnea at rest*
  • No exercise intolerance*
  • Resting pulse oximetry reading > 94% on room air (for patients with respiratory symptoms)* NOTE: *Patients eligible for study regimen A (observation only) are not required to meet the organ function requirements; patients eligible for study regimen B are required to have adequate organ function in the organs that are within the radiotherapy field; patients eligible for study regimens C or D must meet all organ function requirements

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior treatment for cancer allowed provided the patient meet the prior therapy requirements
  • No prior anthracycline (e.g., doxorubicin ir daunorubicin) or ifosfamide chemotherapy for patients enrolled on arm C or arm D
  • No prior radiotherapy to tumor-involved sites
  • No concurrent aprepitant during chemotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346164

  Show 153 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Sheri L. Spunt, MD St. Jude Children's Research Hospital
Investigator: Karyn A. Goodman, MD Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group - Group Chair Office ( Gregory H. Reaman )
Study ID Numbers: CDR0000483702, COG-ARST0332
Study First Received: June 28, 2006
Last Updated: November 5, 2009
ClinicalTrials.gov Identifier: NCT00346164     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult malignant hemangiopericytoma
adult malignant mesenchymoma
adult neurofibrosarcoma
adult alveolar soft-part sarcoma
adult angiosarcoma
adult epithelioid sarcoma
adult extraskeletal chondrosarcoma
adult extraskeletal osteosarcoma
adult fibrosarcoma
adult leiomyosarcoma
adult liposarcoma
adult synovial sarcoma
childhood alveolar soft-part sarcoma
childhood angiosarcoma
childhood epithelioid sarcoma
childhood fibrosarcoma
childhood leiomyosarcoma
childhood liposarcoma
childhood synovial sarcoma
dermatofibrosarcoma protuberans
metastatic childhood soft tissue sarcoma
nonmetastatic childhood soft tissue sarcoma
stage I adult soft tissue sarcoma
stage II adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
adult malignant fibrous histiocytoma
localized childhood malignant fibrous histiocytoma of bone
metastatic childhood malignant fibrous histiocytoma of bone
chondrosarcoma

Additional relevant MeSH terms:
Histiocytoma, Malignant Fibrous
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Histiocytoma, Benign Fibrous
Antineoplastic Agents
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Neoplasms, Connective and Soft Tissue
Neoplasms
Ifosfamide
Histiocytoma
Therapeutic Uses
Sarcoma
Antineoplastic Agents, Alkylating
Neoplasms, Connective Tissue
Neoplasms, Fibrous Tissue
Alkylating Agents

ClinicalTrials.gov processed this record on November 05, 2009