Preoperative IMRT for Soft Tissue Sarcoma of the Extremit... | NCT02785692

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

NCT02785692

Sponsor

Balgrist University Hospital

Status

Terminated

Last Update Posted

Oct 2, 2018Actual

Enrollment

67Actual

Phase

Not provided

Conditions

Sarcoma

Interventions

Radiation

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Principal Investigator has left the Institution

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Jul 2018Actual

Completion Date

Jul 2018Actual

First Submitted Date

May 16, 2016

First Submission Date that Met QC Criteria

May 25, 2016

First Posted Date

May 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2018

Last Update Posted Date

Oct 2, 2018Actual

Name	Class
University of Zurich	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Combined Radiation/ Surgery		All patients treated with combined radiotherapy and surgery at Balgrist University Hospital and University Hospital Zurich	Radiation: Radiation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiation	Radiation	preoperative Radiotherapy/ IMRT	Combined Radiation/ Surgery

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

110 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruno Fuchs, Prof. MD PhD	Balgrist University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Balgrist University Hospital		Zurich		8008	Switzerland
University Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012509	Sarcoma
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011827	Radiation

Ancestor Terms

ID	Term
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided