drugset / Trial / NCT00089544

Preoperative Thalidomide With Radiation Therapy For Patients With Low-Grade Primary Soft Tissue Sarcoma or Thalidomide With Radiation Therapy and Chemotherapy For Patients With High-Grade or Intermediate-Grade Primary Soft Tissue Sarcoma of the Arm, Leg, or Body Wall

NCT00089544

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Thalidomide may stop the growth of soft tissue sarcoma by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and dacarbazine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving thalidomide together with radiation therapy and/or chemotherapy before surgery may shrink the tumor so that it can be removed. This phase II trial is studying how well giving preoperative (before surgery) thalidomide together with radiation therapy works in treating patients with low-grade primary soft tissue sarcoma, and how well giving thalidomide together with radiation therapy, doxorubicin, ifosfamide, and dacarbazine works in treating patients with high-grade or intermediate-grade primary soft tissue sarcoma of the arm, leg, chest wall, or abdominal wall.

Timeline

Start
2004-06-17
Primary completion
2011-09-27
Completion
2013-11-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Dacarbazine Small molecule Intravenous
Subject Doxorubicin Other / unclassified Intravenous
Subject Ifosfamide Small molecule Intravenous
Subject Thalidomide Other / unclassified Oral
Background filgrastim Protein / enzyme biologic Subcutaneous

Indications