Resectable Soft Tissue SarcomaNCT05442333
Adjuvant Versus Neo-adjuvant Radiotherapy in Patients With Resectable Soft Tissue Sarcoma in Extremities : Wound Complications
A study testing surgical resection with safety margin in people with Resectable Soft Tissue Sarcoma and Extremities, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resectable Soft Tissue Sarcoma, Extremities, Radiotherapy Wound Complications
- What is being tested?
- surgical resection with safety margin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Irresectable ESTS
- Round cell ESTS
- recurrent ESTS
- patients who received local irradiation due to other causes
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Being tested
- surgical resection with safety margin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical resection with safety marginProcedure or surgery
Also called pre operative radiotherapy, post operative radiotherapy
- 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.
| Study group | Role | What they receive |
|---|---|---|
| preoperative radiotherapy | Active comparator | The patients which will receive preoperative radiotherapy Receives: Procedure: surgical resection with safety margin |
| postoperative radiotherapy | Active comparator | The patients which will receive postoperative radiotherapy Receives: Procedure: surgical resection with safety margin |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound and local complications
Measured: 12 months
Secondary outcomes (1)
recurrence rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Sep 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziad Khaled Abdullah Abdul Qader, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442333
- Sponsor's protocol ID
- ziad khaled
- Status last verified
- May 2023
- First submitted
- 15 Apr 2022
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Versus Neo-adjuvant Radiotherapy in Patients With Resectable Soft Tissue Sarcoma in Extremities : Wound Complications
- ClinicalTrials.gov ID
- NCT05442333
- Acronym / sponsor ID
- ziad khaled
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative radiotherapy | Active comparator | Procedure: surgical resection with safety marginThe patients which will receive preoperative radiotherapy |
| postoperative radiotherapy | Active comparator | Procedure: surgical resection with safety marginThe patients which will receive postoperative radiotherapy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Irresectable ESTS
- Round cell ESTS
- recurrent ESTS
- patients who received local irradiation due to other causes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical resection with safety marginAlso: pre operative radiotherapy, post operative radiotherapy• 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. | Procedure or surgery | postoperative radiotherapy, preoperative radiotherapy |
Primary outcome
wound and local complications
Time frame: 12 months
1 secondary outcome
recurrence rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical resection with safety margin in people with Resectable Soft Tissue Sarcoma and Extremities, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound and local complications (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.