Name of the Trial
Phase III Randomized Study of Surgery with or without Preoperative Radiotherapy in Patients with Primary Soft Tissue Sarcoma of the Retroperitoneum or Pelvis (ACOSOG-Z9031). See the protocol summary at http://cancer.gov/clinicaltrials/ACOSOG-Z9031.

Principal Investigators
Dr. Peter Pisters and Dr. Brian O'Sullivan, American College of Surgeons Oncology Group

Why Is This Trial Important?
Soft tissue sarcoma is cancer that starts in soft tissues of the body, such as the muscles, fat, tendons and other fibrous tissues, synovial tissues (tissues around the joints), and blood and lymph vessels.

Surgery is the primary treatment for patients with localized soft tissue sarcoma. Often, radiotherapy is used before or after surgery to improve the outcome of patients with soft tissue sarcoma of the head and neck or in an arm or leg. However, soft tissue sarcomas may also arise in the retroperitoneum, the narrow space between the abdominal cavity (which is lined by tissue called the peritoneum) and the posterior body wall. The retroperitoneum contains organs such as the kidneys, pancreas, and adrenal glands. The benefits of adding radiotherapy to surgery for retroperitoneal sarcoma are not clear.

In this trial, researchers are testing whether radiotherapy before surgery will help patients with retroperitoneal sarcoma survive longer without relapse of their cancer. Preoperative radiotherapy is thought to be more effective and less toxic than postoperative radiotherapy for this disease.

"Radiotherapy combined with surgery is the optimal treatment for most patients with sarcoma in an extremity, but we don't know yet if this combination is superior to surgery alone for retroperitoneal sarcoma," said Dr. Pisters. "This trial is designed to definitively answer that question."

Who Can Join This Trial?
Researchers seek to enroll 370 patients aged 18 and over with one of the specified primary soft tissue sarcomas of the retroperitoneum or pelvis. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/ACOSOG-Z9031.

Where Is This Trial Taking Place?
Study sites in the United States and Canada are recruiting patients for this trial. See the list of study sites at http://cancer.gov/clinicaltrials/ACOSOG-Z9031.

Contact Information
See the list of study contacts at http://cancer.gov/clinicaltrials/ACOSOG-Z9031 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.