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Role of Barrier Resection in Local Control for Extremity Recurrent Soft Tissue Sarcomas

NCT02120768 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2014-04-23

No results posted yet for this study

Summary

The randomized, controlled trial is aiming at comparing local control rate between two surgical resections, barrier resection and local wide resection with 1cm or equivalent normal tissues. This is based on the fact that the goal of local surgical treatment is to remove the tumor with negative margin and best functional outcome, but there is a lack of standard principle of surgery. Some surgical oncologists recommended enlarging surgical field in which case the associated muscle was removed from origin to insertion, the previous surgical scar and radiation field were also grossly remove, though there would be extra trauma and unacceptable function impairment, they believe that patients would benefit from "big operations". Most other surgeons would perform a sarcoma resection through normal tissues, and reported a fair local control as long as a negative margin was obtained. As reported by various authors, recurrent STSs are associated with higher risk to develop further recurrence as compared to primary STSs, thus, efforts should focus on this category of STSs to improve outcome.

Conditions

  • Local Recurrence of Malignant Tumor of Soft Tissue

Interventions

PROCEDURE

barrier resection/1cm resection

For Arm "Barrier resection", if a recurrence occurs, patients would be assigned to 1cm resection for their recurrent sarcomas; For Arm "1cm resection", if a recurrence occurs, patients would be assigned to barrier resection for their recurrent sarcomas.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Yong Chen · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-12-31
Completion
2018-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02120768 on ClinicalTrials.gov