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Tracking Information | |||||||||
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First Received Date † | September 7, 2004 | ||||||||
Last Updated Date | February 6, 2009 | ||||||||
Start Date † | August 2004 | ||||||||
Current Primary Outcome Measures † |
Progression-free survival at 5 years [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00091351 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † | |||||||||
Original Secondary Outcome Measures † | |||||||||
Descriptive Information | |||||||||
Brief Title † | Surgery With or Without Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Retroperitoneum or Pelvis | ||||||||
Official Title † | A Phase III Randomized Study of Preoperative Radiation Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcomas (RPS) | ||||||||
Brief Summary | 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. |
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Detailed Description | 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.
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. |
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Study Phase | Phase III | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Active Control | ||||||||
Condition † | Sarcoma | ||||||||
Intervention † |
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Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Completed | ||||||||
Enrollment † | |||||||||
Completion Date | |||||||||
Primary Completion Date | February 2006 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | United States, Canada | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00091351 | ||||||||
Responsible Party | |||||||||
Secondary IDs †† | ACOSOG-Z9031, ECOG-Z9031 | ||||||||
Study Sponsor † | American College of Surgeons | ||||||||
Collaborators †† | National Cancer Institute (NCI) | ||||||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||
Verification Date | February 2006 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |