Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
American College of Surgeons National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00091351 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy before surgery may shrink the tumor so that it can be removed. It is not yet known whether surgery is more effective with or without radiation therapy.
PURPOSE: This randomized phase III trial is studying surgery alone to see how well it works compared to radiation therapy together with surgery in treating patients with primary soft tissue sarcoma of the retroperitoneum or pelvis.
Condition | Intervention | Phase |
---|---|---|
Sarcoma |
Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Randomized Study of Preoperative Radiation Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcomas (RPS) |
Study Start Date: | August 2004 |
Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor grade (low [G1] vs intermediate [G2] vs high [G3/4]), tumor size (< 15 cm vs ≥ 15 cm), and tumor histology (liposarcoma vs non-liposarcoma). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 28 days, 4 months, every 6 months for 5 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this study within 4.5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary soft tissue sarcoma of the retroperitoneum or pelvis (e.g., iliac fossa)
The following histologies are eligible:
The following histologies are not eligible:
Retroperitoneal sarcomas located predominantly in the retroperitoneum extending across the inguinal ligament into the abdominal wall are allowed provided that ≥ 90% of the tumor volume is located within the retroperitoneal space
Patients must have undergone surgical consultation within the past 30 days to confirm and document the feasibility of macroscopically complete resection
No clinical or radiographic evidence of probable metastatic disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Peter W.T. Pisters, MD | M.D. Anderson Cancer Center |
Investigator: | Brian O'Sullivan, MD | Princess Margaret Hospital, Canada |
Study ID Numbers: | CDR0000387803, ACOSOG-Z9031, ECOG-Z9031 |
Study First Received: | September 7, 2004 |
Last Updated: | December 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00091351 |
Health Authority: | United States: Federal Government |
adult alveolar soft-part sarcoma adult angiosarcoma adult epithelioid sarcoma adult fibrosarcoma adult leiomyosarcoma adult liposarcoma |
adult neurofibrosarcoma adult synovial sarcoma adult malignant fibrous histiocytoma stage I adult soft tissue sarcoma stage II adult soft tissue sarcoma stage III adult soft tissue sarcoma |
Histiocytoma, Malignant Fibrous Fibrosarcoma Leiomyosarcoma Histiocytoma, Benign Fibrous Synovial sarcoma Epithelioid sarcoma Malignant mesenchymal tumor Alveolar soft part sarcoma Hemangiosarcoma |
Soft tissue sarcomas Sarcoma, Synovial Neoplasms, Connective and Soft Tissue Liposarcoma Histiocytoma Sarcoma Malignant fibrous histiocytoma Sarcoma, Alveolar Soft Part |
Neoplasms Neoplasms by Histologic Type |