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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02785692
• Other study ID #: 2015-00100
• Status: Terminated
• Start date: January 2016
• Est. completion date: July 2018

Study information

• Verified date: September 2018
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma

Intervention

Radiation:
• Radiation
preoperative Radiotherapy/ IMRT

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zurich
Switzerland	University Hospital	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Balgrist University Hospital	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major and minor wound healing complications		through study completion, minimum 6 weeks post surgery
Secondary	Local and metastatic disease control based on imaging such as CT scans and MRI		maximum 10 years post surgery
Secondary	Overall survival at the latest point of follow- up		maximum 10 years post surgery