Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patienā¦ (NCT00346164) | Clinical Trial Compass
CompletedPhase 3
Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma
United States588 participantsStarted 2007-02-05
Plain-language summary
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.
Who can participate
Age range29 Years
SexALL
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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 ā¦