| Inclusion Criteria: | 1) All patients must be enrolled on CCG99-D9902 for central pathology review to determine if their tumor meets eligibility requirements prior to enrollment on COGARST0332. The diagnosis of NRSTS must be confirmed by central pathology review via enrollment on the COG study CCG99-D9902. Enrollment on CCG99-D9902 must occur prior to or on the same date as enrollment on COGARST0332. Treatment may begin before the central pathology review process is complete as long as the patient has been enrolled on CCG99-D9902 and COGARST0332.
2) (#1 continued): Patients found to have an ineligible diagnosis on central pathology review will be declared ineligible for COGARST0332. If there is any question of whether the patient meets the pathologic eligibility criteria for COGARST0332, delaying enrollment until central pathology review on CCG99-D9902 is complete should be considered so that the patient will not be declared ineligible.
3) (#1 continued): Similarly, if there is uncertainty about the POG grade of the tumor and this factor will influence the treatment assignment, delaying enrollment on COGARST0332 until the central pathology review information from CCG99-D9902 is available should be considered so that the patient does not begin treatment on the incorrect treatment arm.
4) Patients must be enrolled on the study once all eligibility requirements have been met and BEFORE protocol chemotherapy and/or radiotherapy begins.
5) The first biopsy that obtained tissue adequate to determine the diagnosis must have been performed within 12 weeks (84 days) of study enrollment in all patients.
6) Patients enrolled on Treatment Arms A and C must be enrolled within 42 days of the last tumor resection (regardless of whether tumor was present in the surgical specimen) and must start Week 1 chemotherapy within 7 calendar days of enrollment on study.
7) Patients enrolled on Treatment Arm B must begin radiotherapy within 42 days of the last tumor resection.
8) Patients enrolled on Treatment Arms C and D must start Week 1 chemotherapy within 14 calendar days of enrollment on study. An exception will be made for patients enrolled on Arm C who receive brachytherapy. These patients should begin Week 1 chemotherapy within 2 weeks of completion of brachytherapy.
9) Patients who require urgent therapy may begin treatment prior to completion of central pathology review as long as patient has been enrolled on CCG99-D9902 and all other eligibility criteria have been met.
10) Age < 30 years at the time of the biopsy that established the diagnosis of NRSTS.
11) Newly diagnosed NRSTS, confirmed by central pathology review via enrollment on CCG99-D9902, of the following histologic types: "Intermediate (rarely metastasizing)" or "malignant" tumors listed below, as defined in the WHO Classification of Soft Tissue Tumours: Adipocytic tumours - Liposarcoma (dedifferentiated, myxoid, round cell, pleomorphic, mixed-type, not otherwise specified);
12) (#11 continued) Fibroblastic/myofibroblastic tumours - Solitary fibrous tumour, hemangiopericytoma, low grade myofibroblastic sarcoma, myxoinflammatory fibroblastic sarcoma, adult fibrosarcoma, myxofibrosarcoma, low grade fibromyxoid sarcoma (or hyalinizing spindle cell tumour), sclerosing epithelioid fibrosarcoma;
13) (#11 continued) So-called fibrohistiocytic tumours - plexiform fibrohistiocytic tumour, giant cell tumour of soft tissues, pleomorphic 'MFH'/undifferentiated pleomorphic sarcoma, giant cell 'MFH'/undifferentiated pleomorphic sarcoma with giant cells, inflammatory 'MFH'/undifferentiated pleomorphic sarcoma with prominent inflammation; Smooth muscle tumours - Leiomyosarcoma; Pericytic (perivascular) tumours - Malignant glomus tumour, glomangiosarcoma; Vascular tumours - Angiosarcoma of soft tissue; Chondro-osseous tumours - Mesenchymal chondrosarcoma, extraskeletal osteosarcoma;
14) (#11 continued) Tumours of uncertain differentiation - Angiomatoid fibrous histiocytoma, ossifying fibromyxoid tumour, 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 tumour, intimal sarcoma;
15) (#11 continued) Malignant peripheral nerve sheath tumor; Dermatofibrosarcoma protuberans - Only tumors that are both non-metastatic and grossly resected; Embryonal sarcoma of the liver; Unclassified soft tissue sarcomas that are too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called "undifferentiated soft tissue sarcoma" or "soft tissue sarcoma NOS").
16) Tumor Resection: Gross total resection of the primary tumor prior to enrollment on COGARST0332 is required except in the case of: 1) Non-metastatic high grade tumor > 5cm in maximal diameter and gross or microscopic residual tumor is anticipated following resection; 2) Tumor of either high or low grade that cannot be grossly excised without unacceptable morbidity; 3) High grade tumor with metastases. Patients with metastatic low grade tumors whose disease at all sites is amenable to gross resection must undergo gross excision of all sites of tumor involvement prior to study enrollment.
17) Patients with non-metastatic and metastastic disease are eligible.
18) Patients with clinical or radiologic evidence of regional lymph node enlargement and those with epithelioid sarcoma or clear cell sarcoma must undergo sentinel lymph node biopsies or lymph node sampling to confirm the status of regional lymph nodes prior to study enrollment. An exception will be made 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.
19) 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 either before study entry or, in Treatment Arm D patients only, at the time of Week 13 definitive surgery. In patients to be enrolled on Treatment Arm C, lymph node dissection must be performed prior to study enrollment.
20) Patients who will be categorized as having metastatic disease must undergo a biopsy to confirm the presence of metastatic tumor if all metastases are < 1 cm in maximal diameter. An exception will be made in cases where the study radiologist reviews the imaging and indicates that a biopsy is not needed to confirm that the patient has metastatic disease.
21) Performance Level: Lansky performance status score >/= 50 for patients </= 16 years of age. Karnofsky performance status score >/= 50 for patients > 16 years of age.
22) No prior anthracycline (e.g., doxorubicin, daunorubicin) or ifosfamide chemotherapy if patient will be enrolled on Treatment Arm C or D. No prior radiotherapy to tumor-involved sites. Prior use of steroids is acceptable. Patients previously treated for cancer are eligible provided they meet the prior therapy requirements.
23) Organ Function Requirements: Patients eligible for the observation arm (Treatment A) are not required to meet the organ function requirements listed below. Patients eligible for the radiotherapy arm (Treatment B) are required to have adequate organ function in the organs that will be within the radiotherapy field. All of these patients must meet the criteria for bone marrow function. Patients eligible for the chemotherapy treatment arms (Treatments C and D) must meet all organ function requirements.
24) Adequate bone marrow function defined as: Absolute neutrophil count >/= 1000/microliters; Platelet count >/= 100,000/microliters.
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Criteria truncated, please contact Prinicipal Investigator's office for full criteria |