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

Stopped early · Phase 2

Conditions studied: Recurrent Adult Soft Tissue Sarcoma, Stage I Adult Soft Tissue Sarcoma AJCC v7, Stage II Adult Soft Tissue Sarcoma AJCC v7, Stage III Adult Soft Tissue Sarcoma AJCC v7

In brief

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.

Key facts

Study ID

NCT00089544

Run by

National Cancer Institute (NCI)

People needed

23

Starts

2004-06-17

Expected to finish

2013-11-05

Last updated by the study team

2018-04-13

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of primary soft tissue sarcoma
• T2a or T2b disease
• Superficial or deep tumor
• Grade 1, 2, 3, or 4
• Tumor located on the upper extremity (including shoulder), lower extremity (including hip), or trunk
• Meets 1 of the following criteria:
• Tumor ? 8 cm in maximal diameter and grade 3 or 4 (intermediate or high grade) (cohort A)
• Tumor > 5 cm in maximal diameter and grade 1 or 2 (low grade) (cohort B)
• Locally recurrent disease allowed provided there has been no prior radiotherapy to the primary tumor
• No histologically confirmed rhabdomyosarcoma, extraosseous Ewing's primitive neuroectodermal tumors, osteosarcoma or chondrosarcoma, Kaposi's sarcoma, angiosarcoma, desmoid tumors, or dermatofibrosarcoma protuberans
• No overt evidence of lung metastases (CT scan evidence of small incidental lesions without histologic diagnosis allowed)
• No evidence of other metastases
• No sarcoma of the head, neck, intra-abdominal, or retroperitoneal region
• Performance status - Zubrod 0-1
• At least 2 years
• Absolute neutrophil count ? 1,500/mm\^3
• Platelet count ? 120,000/mm\^3
• Hemoglobin ? 8.0 g/dL (cohort A)
• No known hypercoagulable disorders, such as the following:
• APC resistance (factor V Leiden)
• Protein S deficiency
• Protein C deficiency
• Antithrombin III deficiency
• Hyperhomocystinemia
• Dysplasminogenemia

Where it is running

• Radiation Therapy Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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