Adjuvant Versus Neo-adjuvant Radiotherapy in Patients With Resectable Soft Tissue Sarcoma in Extremities : Wound Complications
Primary Purpose
Resectable Soft Tissue Sarcoma, Extremities, Radiotherapy Wound Complications
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
surgical resection with safety margin
Sponsored by
About this trial
This is an interventional treatment trial for Resectable Soft Tissue Sarcoma
Eligibility Criteria
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
Sites / Locations
- Ain Shams University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
preoperative radiotherapy
postoperative radiotherapy
Arm Description
The patients which will receive preoperative radiotherapy
The patients which will receive postoperative radiotherapy
Outcomes
Primary Outcome Measures
wound and local complications
Secondary Outcome Measures
recurrence rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05442333
Brief Title
Adjuvant Versus Neo-adjuvant Radiotherapy in Patients With Resectable Soft Tissue Sarcoma in Extremities : Wound Complications
Official Title
Adjuvant Versus Neo-adjuvant Radiotherapy in Patients With Resectable Soft Tissue Sarcoma in Extremities : Wound Complications
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resectable Soft Tissue Sarcoma, Extremities, Radiotherapy Wound Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
preoperative radiotherapy
Arm Type
Active Comparator
Arm Description
The patients which will receive preoperative radiotherapy
Arm Title
postoperative radiotherapy
Arm Type
Active Comparator
Arm Description
The patients which will receive postoperative radiotherapy
Intervention Type
Procedure
Intervention Name(s)
surgical resection with safety margin
Other Intervention Name(s)
pre operative radiotherapy, post operative radiotherapy
Intervention Description
• 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.
Primary Outcome Measure Information:
Title
wound and local complications
Time Frame
12 months
Secondary Outcome Measure Information:
Title
recurrence rate
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
ZIP/Postal Code
02
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
12 months
Learn more about this trial
Adjuvant Versus Neo-adjuvant Radiotherapy in Patients With Resectable Soft Tissue Sarcoma in Extremities : Wound Complications
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