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

NCT05442333 | Unknown DMC

• 1 other identifier: ziad khaled
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Resectable Soft Tissue Sarcoma; Extremities; Radiotherapy Wound Complications

Outcome Measures

Primary Outcomes (1)

• wound and local complications

  12 months

Secondary Outcomes (1)

• recurrence rate

  2 years

Study Arms (2)

preoperative radiotherapy

ACTIVE COMPARATOR

The patients which will receive preoperative radiotherapy

Procedure: surgical resection with safety margin

postoperative radiotherapy

ACTIVE COMPARATOR

The patients which will receive postoperative radiotherapy

Procedure: surgical resection with safety margin

Interventions

surgical resection with safety margin PROCEDURE

• 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

postoperative radiotherapy; preoperative radiotherapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, 02, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: orthopedic oncology department assistant lecturer

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: July 5, 2022
• Study Start: September 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months

Locations

EG (1)