drugset / Trial / NCT00346164

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

NCT00346164

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2007-02-05
Primary completion
2014-09-05
Completion
2022-03-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified 37.5 mg/m2 Intravenous
Subject Ifosfamide Small molecule 3 g Intravenous