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COMPLETED Phase 3

Surgery With or Without Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Retroperitoneum or Pelvis

NCT00091351 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • PROCEDURE conventional surgery
  • RADIATION radiation therapy

Study Locations (20)

Illinois

  • Rush-Copley Cancer Care Center — Aurora
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University — Chicago
  • Joliet Oncology Hematology Associates, Limited - West — Joliet
  • Cardinal Bernardin Cancer Center at Loyola University Medical Center — Maywood
  • Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields — Olympia Fields
  • Carle Cancer Center at Carle Foundation Hospital — Urbana
  • CCOP - Carle Cancer Center — Urbana

Georgia

  • Phoebe Cancer Center at Phoebe Putney Memorial Hospital — Albany
  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center — Savannah

Indiana

  • St. Francis Hospital and Health Centers - Beech Grove Campus — Beech Grove
  • Saint Anthony Memorial Health Centers — Michigan City

Arkansas

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences — Little Rock

California

  • City of Hope Comprehensive Cancer Center — Duarte

Colorado

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center — Aurora

District of Columbia

  • George Washington University Medical Center — Washington D.C.

Florida

  • University of Florida Shands Cancer Center — Gainesville

Trial Details

FieldValue
Enrollment Target 370 participants
Start Date 2004-08
Est. Completion 2006-02
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00091351

The ClinicalTrials.gov registry entry for NCT00091351 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Sarcoma appearing as the primary indexed condition, and to 2 interventions — of which conventional surgery is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00091351 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Illinois, Georgia, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00091351 about?

NCT00091351 is a clinical study titled "Surgery With or Without Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Retroperitoneum or Pelvis". 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 st...

What is the current status of trial NCT00091351?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 370 participants. The study started on 2004-08. Estimated completion is 2006-02.

What conditions does trial NCT00091351 study?

This clinical trial studies the following conditions: Sarcoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00091351?

The interventions under investigation include: conventional surgery (PROCEDURE), radiation therapy (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00091351?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00091351 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial