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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05442333
Enrollment
20
Registered
2022-07-05
Start date
2021-09-01
Completion date
2023-06-30
Last updated
2023-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extremities, Radiotherapy Wound Complications, Resectable Soft Tissue Sarcoma

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.

Interventions

PROCEDUREsurgical 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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
wound and local complications12 months

Secondary

MeasureTime frame
recurrence rate2 years

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026