Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patien… (NCT00346164) | Clinical Trial Compass
CompletedPhase 3
Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma
United States, Australia, Canada588 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 range
29 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.