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

NCT02785692 | Terminated

• 1 other identifier: 2015-00100
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Major and minor wound healing complications

  through study completion, minimum 6 weeks post surgery

Secondary Outcomes (2)

• Local and metastatic disease control based on imaging such as CT scans and MRI

  maximum 10 years post surgery

• Overall survival at the latest point of follow- up

  maximum 10 years post surgery

Study Arms (1)

Combined Radiation/ Surgery

All patients treated with combined radiotherapy and surgery at Balgrist University Hospital and University Hospital Zurich

Radiation: Radiation

Interventions

Radiation RADIATION

preoperative Radiotherapy/ IMRT

Combined Radiation/ Surgery

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Balgrist University Hospital: lead
• University of Zurich: collaborator

Study Sites (2)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

University Hospital

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Sarcoma; Postoperative Complications

Interventions

Radiation

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Bruno Fuchs, Prof. MD PhD

  Balgrist University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 30, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)