Preoperative IMRT for Soft Tissue Sarcoma of the Extremities and Trunk: Low Rate of Wound Complications

September 30, 2018 updated by: Balgrist University Hospital
Postoperative wound healing complications following preoperative radiotherapy represent a severe problem in the treatment of malignant soft tissue tumors, and are reported to be 34% and more. The literature discusses intensely the advantages and disadvantages of this multimodal treatment concept and there are different opinions. The Canadian prospective randomized NCIC SR2 trial showed increased wound complication rates in the study arm receiving preoperative radiation. The Sarcoma Center Zurich pursues mainly this treatment concept and the results shall now be analysed and published. The approach is to show that not only the complication rates are comparable to international bench marks, but also the (still intermediate time) local control rates.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Introduction: The Canadian prospective randomized NCIC SR2 trial tested the sequence of radiation and surgery for soft tissue sarcoma of the extremities. Similar disease control rates following pre- versus postoperative non-intensity modulated radiation therapy (non-IMRT) was found, with increased wound complications (17% vs 35%) in the preoperative radiation arm, [95% CI 5-30], p=0·01).

The investigators assessed a single center preoperative IMRT (or IMRT-equivalent highly conformal three dimensional conventional RT (3DcRT)) cohort with respect to the wound complication rate (WCR). The hypothesis was that a lower WCR rate was achieved in the era of IMRT as compared to the non-IMRT era when the Canadian Trial was conducted.

Methods: 67 consecutive patients irradiated with 50Gy in 25 fractions between 3/2008-3/2016 with preoperative IMRT (n=48, 72%) or highly conformal IMRT-equivalent 3DcRT dose distribution (n=19, 28%) were assessed. All patients were previously discussed at the weekly interdisciplinary sarcoma board of the Sarcoma Center Zurich.

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8008
        • Balgrist University Hospital
      • Zurich, Switzerland, 8008
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

67 patients with histological proven malignant soft tissue sarcomas who underwent preoperative radiotherapy followed by surgical tumor resection

Description

Inclusion Criteria:

  • Patients with a malignant soft tissue tumour
  • Patients who underwent preoperative radiotherapy at the department of radiation oncology, University Hospital Zurich (USZ)
  • Surgical treatment at Balgrist University Hospital between 2007 and 2016

Exclusion Criteria:

  • Vulnerability
  • Previous chemotherapy
  • Previous radiotherapy on the affected site
  • Patient's wish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Combined Radiation/ Surgery
All patients treated with combined radiotherapy and surgery at Balgrist University Hospital and University Hospital Zurich
Radiation: Radiation
preoperative Radiotherapy/ IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major and minor wound healing complications
Time Frame: through study completion, minimum 6 weeks post surgery
through study completion, minimum 6 weeks post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Local and metastatic disease control based on imaging such as CT scans and MRI
Time Frame: maximum 10 years post surgery
maximum 10 years post surgery
Overall survival at the latest point of follow- up
Time Frame: maximum 10 years post surgery
maximum 10 years post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balgrist University Hospital

Collaborators

University of Zurich

Investigators

  • Study Chair: Bruno Fuchs, Prof. MD PhD, Balgrist University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

May 16, 2016

First Submitted That Met QC Criteria

May 25, 2016

First Posted (Estimate)

May 30, 2016

Study Record Updates

Last Update Posted (Actual)

October 2, 2018

Last Update Submitted That Met QC Criteria

September 30, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-00100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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