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

NCT05442333 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-05-17

No results posted yet for this study

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

Conditions

  • Resectable Soft Tissue Sarcoma
  • Extremities
  • Radiotherapy Wound Complications

Interventions

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05442333 on ClinicalTrials.gov