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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02785692
Enrollment
67
Registered
2016-05-30
Start date
2016-01-31
Completion date
2018-07-31
Last updated
2018-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma

Keywords

soft tissue sarcoma, IMRT and sarcoma, preoperative highly conformal radiation therapy, soft tissue sarcoma and wound healing, postoperative complications, treatment tolerance of soft tissue IMRT

Brief 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.

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.

Interventions

RADIATIONRadiation

preoperative Radiotherapy/ IMRT

Sponsors

University of Zurich
CollaboratorOTHER
Balgrist University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Major and minor wound healing complicationsthrough study completion, minimum 6 weeks post surgery

Secondary

MeasureTime frame
Local and metastatic disease control based on imaging such as CT scans and MRImaximum 10 years post surgery
Overall survival at the latest point of follow- upmaximum 10 years post surgery

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026