An interventional study of surgical resection with safety margin in Resectable Soft Tissue Sarcoma, Extremities and Radiotherapy Wound Complications, sponsored by Ain Shams University. Active, not recruiting at 1 site in Egypt. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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 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.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
The patients which will receive preoperative radiotherapy
Procedure: surgical resection with safety margin
The patients which will receive postoperative radiotherapy
Procedure: surgical resection with safety margin
• The patients with preoperative radiotherapy: 1. will be assessed 3 weeks post radiation regarding wound signs of infection (redness, hotness or discharge). 2. 6 weeks post radiation for wound dehiscence 3. 3 months post radiation for local swelling or recurrence 4. 6 months post radiation for local recurrence, joint stiffness or pathological fractures. The patients with postoperative radiotherapy: 1. will be assessed 3 weeks post radiation regarding wound signs of infection (redness, hotness or discharge). 2. 6 weeks post radiation for wound dehiscence 3. 3 months post radiation for local swelling or recurrence 4. 6 months post radiation for local recurrence, joint stiffness or pathological fractures.
Also known as: pre operative radiotherapy, post operative radiotherapy
wound and local complications
Time frame: 12 months
recurrence rate
Time frame: 2 years
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Ain Shams University