Adjuvant Versus Neo-adjuvant Radiotherapy in Patients With Resectable Soft Tissue Sarcoma in Extremities : Wound Complications

Extremity soft tissue sarcomas (ESTS)s are rare mesenchymal cancers that considered a challenge for orthopaedic surgeons. Soft tissue sarcomas (STS) comprise less than 1% of malignant cancers, commonly occur in the proximal extremities and trunk. Limb-sparing surgery mostly are targeted in most of the patients, so adjuvant or neoadjuvant radiotherapy is usually added. Preoperative radiotherapy (neoadjuvant) or postoperative radiotherapy (adjuvant) offers local control and survival rates, but the local complications are controversial. However, different retrospective studies had shown that preoperative radiotherapy cause higher wound complication rate, while both preoperative and postoperative radiotherapy had the same results regarding local recurrence

Study Overview

• Status: Active, not recruiting
• Conditions: Resectable Soft Tissue Sarcoma; Extremities; Radiotherapy Wound Complications
• Intervention / Treatment: Procedure: surgical resection with safety margin

Detailed Description

Study Tools :The patients will be managed as follows:

Primary (Preoperative) Diagnosis and Evaluation

Clinical Evaluation. History. General examination. Local examination.

Radiological Evaluation:

Plain X-ray for the affected limb to determine presence of any bone affection or invasion.

Preoperative MRI scan to determine the extent of soft tissue, bone and neurovascular bundle invasion.

Preoperative bone scan to determine skeletal metastatic load.

Perioperative protocol:

Preoperative radiotherapy 3-6 weeks before surgical excision. Postoperative radiotherapy 3- 6 weeks or more after surgical excision Tissue diagnosis will be obtained.

Operative management:

Surgical excision of whole tumour with wide safety margin.

Data collection:

Patient demographics (age, sex). Activity level Primary sarcoma type Patient comorbidities Timing of Preoperative radiotherapy if present. Timing of Postoperative radiotherapy if present. Time from diagnosis to surgery. recurrence Operative time (minutes) measured from skin incision to wound closure. Follow up regarding wound complications, local recurrence or infection. local recurrence will be followed up till the end of the study

Follow up strategy:

The patients with preoperative radiotherapy:

will be assessed 2 weeks postoperative regarding wound signs of infection (redness, hotness or discharge).

1 month postoperatively for wound complete closure and exclude signs of infection.

3 months postoperatively for wound dehiscence, swelling or local recurrence. 6 months postoperatively for local recurrence, pathological fractures or joint stiffness

The patients with postoperative radiotherapy:

will be assessed 3 weeks post radiation regarding wound signs of infection (redness, hotness or discharge).

6 weeks post radiation for wound dehiscence 3 months post radiation for local swelling or recurrence 6 months post radiation for local recurrence, joint stiffness or pathological fractures.

Statistical Analysis: Statistical package for social science (SPSS 15.0.1 for windows ; 〖SPSS Inc,Chicago,IL,2001). Data will be presented as Mean and Standard deviation ( +/-SD) for quantitative parametric data , and Median and Interquartile range for quantitative non parametric data. Frequency and percentage will be used for presenting qualitative data. Suitable analysis will be done according to the type of data obtained. P<0.05 will be considered significant.

Statistical Package: data entry and statistical analysis of the collected data will be performed using reliable software program.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Sex: both sexes.
• Lesion: any soft tissue sarcoma in upper or lower limbs (synovial sarcoma, liposarcoma, fibrosarcoma and others)
• age more than 16 years old

Exclusion Criteria:

• Irresectable ESTS
• Round cell ESTS
• recurrent ESTS
• patients who received local irradiation due to other causes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: preoperative radiotherapy; The patients which will receive preoperative radiotherapy	Procedure: surgical resection with safety margin; • The patients with preoperative radiotherapy: will be assessed 3 weeks post radiation regarding wound signs of infection (redness, hotness or discharge).; 6 weeks post radiation for wound dehiscence; 3 months post radiation for local swelling or recurrence; 6 months post radiation for local recurrence, joint stiffness or pathological fractures. The patients with postoperative radiotherapy: will be assessed 3 weeks post radiation regarding wound signs of infection (redness, hotness or discharge).; 6 weeks post radiation for wound dehiscence; 3 months post radiation for local swelling or recurrence; 6 months post radiation for local recurrence, joint stiffness or pathological fractures.; Other Names: pre operative radiotherapy; post operative radiotherapy
Active Comparator: postoperative radiotherapy; The patients which will receive postoperative radiotherapy	Procedure: surgical resection with safety margin; • The patients with preoperative radiotherapy: will be assessed 3 weeks post radiation regarding wound signs of infection (redness, hotness or discharge).; 6 weeks post radiation for wound dehiscence; 3 months post radiation for local swelling or recurrence; 6 months post radiation for local recurrence, joint stiffness or pathological fractures. The patients with postoperative radiotherapy: will be assessed 3 weeks post radiation regarding wound signs of infection (redness, hotness or discharge).; 6 weeks post radiation for wound dehiscence; 3 months post radiation for local swelling or recurrence; 6 months post radiation for local recurrence, joint stiffness or pathological fractures.; Other Names: pre operative radiotherapy; post operative radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
wound and local complications	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
recurrence rate	2 years

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Wounds and Injuries
• Other Study ID Numbers: ziad khaled

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 12 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No