Clinical trial NCT02785692: Preoperative IMRT for Soft Tissue Sarcoma of the Extremities and Trunk: Low Rate of Wound Complications
Official title: Preoperative IMRT for Soft Tissue Sarcoma of the Extremities and Trunk: Low Rate of Wound Complications
Study type: OBSERVATIONAL
Overall status: TERMINATED
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
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2016-05-30
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major and minor wound healing complications
timeFrame: through study completion, minimum 6 weeks post surgery
Secondary outcomes:
measure: Local and metastatic disease control based on imaging such as CT scans and MRI
timeFrame: maximum 10 years post surgery
measure: Overall survival at the latest point of follow- up
timeFrame: maximum 10 years post surgery
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
city: Zurich
country: Switzerland
facility: University Hospital
Study officials:
affiliation: Balgrist University Hospital
name: Bruno Fuchs, Prof. MD PhD
role: STUDY_CHAIR
References: