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

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ClinicalTrials.gov Identifier: NCT02120768
Recruitment Status : Unknown
Verified April 2014 by Shi Yingqiang, Fudan University.
Recruitment status was:  Recruiting
First Posted : April 23, 2014
Last Update Posted : April 23, 2014
Sponsor:
Information provided by (Responsible Party):
Shi Yingqiang, Fudan University

Brief 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.

Condition or disease Intervention/treatment Phase
Local Recurrence of Malignant Tumor of Soft Tissue Procedure: barrier resection/1cm resection Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study of The Role of Barrier Resection in Local Control in Treatment of Extremity Soft Tissue Sarcomas
Study Start Date : March 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2018

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Arm Intervention/treatment
Experimental: Barrier resection
Barrier resection was defined as "en bloc" removal of tumor with surrounding barriers. The barriers include muscular fascia, vascular adventitia, epineurium and periosteum, in some cases where there is no barrier, 3-5cm of healthy tissue is considered equivalent. Barrier resection was developed according to the above characteristics of STSs, which featured with the fact that sarcomas take the path of least resistance and initially grow within the anatomical compartment in which they arose, and the phenomenon that skip metastases are limited within the same anatomic compartment in which the primary lesion is located.Further surgery would be 1cm resection if a recurrence occurs.
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.

Active Comparator: 1 cm resection
Surgical margin width is determined mainly by the distance from the tumor edge to the periphery of the specimen, different margin width of 1-5cm has been recommended for obtaining a safe margin,but the local recurrence rate remains to be 10-25%. Further surgery would be barrier resection if a recurrence occurs.
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.




Primary Outcome Measures :
  1. Percentage of participants with local recurrence. [ Time Frame: up to 2 years ]

Secondary Outcome Measures :
  1. percentage of participants with surgical complications [ Time Frame: up to 30 days ]


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Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed recurrent ESTS.
  2. Confirmed imaging targets, resectable, no metastasis.
  3. No radiochemotherapy in the past 3 months.
  4. ECOG status of 0-1.
  5. Age between 14 and 80.
  6. WBC over 3000/µL,Neutriphil ≥1,500/µL, PLT ≥100,000/µL.
  7. Understand the and sign the consent form with compliance.

Exclusion Criteria:

  1. Pregnant or lactating.
  2. Metastasis.
  3. Radiotherapy or chemotherapy in the past 3 months.
  4. Another malignancy in the past 3 years.
  5. Uncontrollable heart disease or psychologically unstable.
  6. Severe infection.
  7. In recovery of last operation.
  8. Preoperative MSTS score less than 15.
  9. Other dysfunctions or situations which assessed to be unsuitable for the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120768


Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Lingling Pan    0862164175590    yingqiangshi@126.com   
Contact: Yong Chen    0862164175590    chenyongfudan@gmail.com   
Principal Investigator: yingqiang Shi         
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Yong Chen Fudan University

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Responsible Party: Shi Yingqiang, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT02120768     History of Changes
Other Study ID Numbers: 1310128-1-1312
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014

Keywords provided by Shi Yingqiang, Fudan University:
Barrier resection
Local recurrence
Complication

Additional relevant MeSH terms:
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Sarcoma
Recurrence
Neoplasms
Soft Tissue Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes
Neoplasms by Site