In this context, the term soft tissue refers to tissues that connect, support, or surround other structures and organs of the body. Soft tissue includes muscles, tendons (bands of fiber that connect muscles to bones), fibrous tissues, fat, blood vessels, nerves, and synovial tissues (tissues around joints).

There are many different kinds of soft tissue sarcomas. They are grouped together because they share certain microscopic characteristics, produce similar symptoms, and are generally treated in similar ways. (Bone tumors, also known as osteosarcomas, are also called sarcomas, but are in a separate category because they have different clinical and microscopic characteristics and are treated differently.)

Sarcomas can invade surrounding tissue and can metastasize (spread) to other organs of the body, forming secondary tumors. The cells of secondary tumors are similar to those of the primary (original) cancer. Secondary tumors are referred to as "metastatic soft tissue sarcoma" because they are part of the same cancer and are not a new disease.

Some tumors of the soft tissue are benign (noncancerous). These tumors do not spread and are rarely life-threatening. However, benign tumors can crowd nearby organs and cause symptoms or interfere with normal body functions.

What are the possible causes of soft tissue sarcomas?

Scientists do not fully understand why some people develop sarcomas while the vast majority do not. However, by identifying common characteristics in groups with unusually high occurrence rates, researchers have been able to single out some factors that may play a role in causing soft tissue sarcomas.

Studies suggest that workers who are exposed to phenoxyacetic acid in herbicides and chlorophenols in wood preservatives may have an increased risk of developing soft tissue sarcomas. An unusual percentage of patients with a rare blood vessel tumor, angiosarcoma of the liver, have been exposed to vinyl chloride in their work. This substance is used in the manufacture of certain plastics.

In the early 1900s, when scientists were just discovering the potential uses of radiation to treat disease, little was known about safe dosage levels and precise methods of delivery. At that time, radiation was used to treat a variety of noncancerous medical problems, including enlargement of the tonsils, adenoids, and thymus gland. Later, researchers found that high doses of radiation caused soft tissue sarcomas in some patients. Because of this risk, radiation treatment for cancer is now planned to ensure that the maximum dosage of radiation is delivered to diseased tissue while surrounding healthy tissue is protected as much as possible.

Researchers believe that a retrovirus plays an indirect role in the development of Kaposi's sarcoma, a rare cancer of the cells that line blood vessels in the skin and mucus membranes. Kaposi's sarcoma often occurs in patients with AIDS (acquired immune deficiency syndrome). AIDS-related Kaposi's sarcoma, however, has different characteristics and is treated differently than typical soft tissue sarcomas.

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Doxorubicin with or without ifosfamide in treating patients with locally advanced or metastatic soft tissue sarcoma - Clinical Trial Review
From Journal of Drugs in Dermatology, 8/1/03

Sponsored by: EORTC Soft Tissue and Bone Sarcoma Cooperative Group

RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether doxorubicin is more effective with or without ifosfamide in treating soft tissue sarcoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of doxorubicin with or without ifosfamide in treating patients who have locally advanced or metastatic soft tissue sarcoma.

Study Type: Interventional

Study Design: Treatment

OBJECTIVES:

* Compare the progression-free and overall survival of patients with locally advanced or metastatic soft tissue sarcoma treated with doxorubicin with vs. without ifosfamide as first-line therapy.

* Compare the response in patients treated with these regimens.

* Compare the treatment-related mortality of patients treated with these regimens.

* Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to WHO performance status (0 vs. 1), age group (less than 50 years of age vs. 50 years of age and over), presence of liver metastases (yes vs. no), histological grade (2 vs. 3), and participating center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive doxorubicin IV on day 1.

* Arm II: Patients receive doxorubicin IV on days 1-3 and ifosfamide IV over 4 hours on days 1-4. In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. * Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter.

Ages eligible for study: 18 years - 60 years, both genders

DISEASE CHARACTERISTICS:

* Histologically confirmed soft tissue sarcoma

* Locally advanced unresectable * OR metastatic disease

* High-grade (grade 2-3) disease according to the FNLCC grading system

NOTE: * Disease that could prove resectable (including pulmonary metastasectomy) after a response to chemotherapy is allowed

* The following tumor types are eligible:

* Malignant fibrous histiocytoma

* Myxoid and round cell liposarcoma, pleomorphic liposarcoma, or dedifferentiated liposarcoma

* Pleomorphic rhabdomyosarcoma

* Synovial sarcoma

* Myxofibrosarcoma, intermediate and high-grade

* Fibrosarcoma

* Leiomyosarcoma

* Angiosarcoma

* Malignant peripheral nerve sheath tumor

* Epithelioid sarcoma

* The following tumor types are not eligible:

* Gastrointestinal stromal tumor

* Uterine leiomyosarcoma

* Mixed mesodermal tumor

* Chondrosarcoma

* Malignant mesothelioma

* Neuroblastoma

* Osteosarcoma

* Ewing's sarcoma/primitive neuroectodermal tumor

* Desmoplastic small round cell tumor

* Embryonal rhabdomyosarcoma

* Alveolar soft part sarcoma

* Must have a measurable lesion with clinical evidence of progression within the past 6 weeks

* Osseous lesions and pleural effusions are not considered measurable

* No known or symptomatic CNS metastases

Patient Characteristics:

Performance status

* WHO 0-1

Hematopoietic

* Absolute neutrophil count at least 2,000/[mm.sup.3]

* Platelet count at least 100,000/[mm.sup.3]

Hepatic

* Bilirubin no greater than 1.8 mg/dL

* Albumin at least 2.5 g/dL

Renal

* Creatinine no greater than 1.4 mg/dL OR

* Creatinine clearance greater than 65 mL/min

Cardiovascular

* LVEF normal by echocardiography or MUGA

* No history of cardiovascular disease

Other

* Not pregnant

* Negative pregnancy test

* Fertile patients must use effective contraception

* No other severe medical illness

* No psychosis

* No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell skin cancer

* No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up schedule

PRIOR CONCURRENT THERAPY:

Chemotherapy

* No prior chemotherapy for advanced or metastatic disease

* Prior adjuvant chemotherapy allowed provided there was no disease progression within 6 months after completion of treatment

Radiotherapy

* No prior radiotherapy to the sole index lesion

Location and Contact Information:

Institute of Cancer Research--UK, Sutton, England, SM2 5NG, United Kingdom; Ian Robert Judson, MA, MD, FRCP Study Chair, National Cancer Research Institute (NCRI) Tel: 44-208-722-4302

Denmark United Kingdom, England

A total of 450 patients will be accrued for this study within 4 years

Study ID Numbers CDR0000302584; EORTC-62012

NLM Identifier NCT00061984

Return to Soft tissue sarcoma

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