SarcomaNCT02785692
Preoperative IMRT for Soft Tissue Sarcoma of the Extremities and Trunk: Low Rate of Wound Complications
An observational study of Sarcoma, run by Balgrist University Hospital at 2 sites in Switzerland.
Trial summary
Postoperative wound healing complications following preoperative radiotherapy represent a severe problem in the treatment of malignant soft tissue tumors, and are reported to be 34% and more. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- Radiation
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jan 2016to Jul 2018
- Phase
- Observational
- 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 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 67 patients with histological proven malignant soft tissue sarcomas who underwent preoperative radiotherapy followed by surgical tumor resection
Who may be able to join
- Patients with a malignant soft tissue tumour
- Patients who underwent preoperative radiotherapy at the department of radiation oncology, University Hospital Zurich (USZ)
- Surgical treatment at Balgrist University Hospital between 2007 and 2016
Who cannot join
- Vulnerability
- Previous chemotherapy
- Previous radiotherapy on the affected site
- Patient's wish
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Balgrist University Hospital
Zurich, 8008
University Hospital
Zurich, 8008
About this study
Postoperative wound healing complications following preoperative radiotherapy represent a severe problem in the treatment of malignant soft tissue tumors, and are reported to be 34% and more. The literature discusses intensely the advantages and disadvantages of this multimodal treatment concept and there are different opinions. The Canadian prospective randomized NCIC SR2 trial showed increased wound complication rates in the study arm receiving preoperative radiation. The Sarcoma Center Zurich pursues mainly this treatment concept and the results shall now be analysed and published. The approach is to show that not only the complication rates are comparable to international bench marks, but also the (still intermediate time) local control rates.
Read the detailed description
Introduction: The Canadian prospective randomized NCIC SR2 trial tested the sequence of radiation and surgery for soft tissue sarcoma of the extremities. Similar disease control rates following pre- versus postoperative non-intensity modulated radiation therapy (non-IMRT) was found, with increased wound complications (17% vs 35%) in the preoperative radiation arm, [95% CI 5-30], p=0·01).
The investigators assessed a single center preoperative IMRT (or IMRT-equivalent highly conformal three dimensional conventional RT (3DcRT)) cohort with respect to the wound complication rate (WCR). The hypothesis was that a lower WCR rate was achieved in the era of IMRT as compared to the non-IMRT era when the Canadian Trial was conducted.
Methods: 67 consecutive patients irradiated with 50Gy in 25 fractions between 3/2008-3/2016 with preoperative IMRT (n=48, 72%) or highly conformal IMRT-equivalent 3DcRT dose distribution (n=19, 28%) were assessed. All patients were previously discussed at the weekly interdisciplinary sarcoma board of the Sarcoma Center Zurich.
- Conditions
- Sarcoma
- Being tested
- Radiation
- Keywords
- soft tissue sarcoma, IMRT and sarcoma, preoperative highly conformal radiation therapy, soft tissue sarcoma and wound healing, postoperative complications, treatment tolerance of soft tissue IMRT
- Medical subject headings
- Sarcoma, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
preoperative Radiotherapy/ IMRT
| Study group | Role | What they receive |
|---|---|---|
| Combined Radiation/ Surgery | All patients treated with combined radiotherapy and surgery at Balgrist University Hospital and University Hospital Zurich Receives: Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major and minor wound healing complications
Measured: through study completion, minimum 6 weeks post surgery
Secondary outcomes (2)
Local and metastatic disease control based on imaging such as CT scans and MRI
Measured: maximum 10 years post surgery
Overall survival at the latest point of follow- up
Measured: maximum 10 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2018
- Study completionJul 2018
Why it stopped: Principal Investigator has left the Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Bruno Fuchs, Prof. MD PhD, Study chair, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785692
- Sponsor's protocol ID
- 2015-00100
- Other IDs
- 2015
- Status last verified
- Sep 2018
- First submitted
- 16 May 2016
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative IMRT for Soft Tissue Sarcoma of the Extremities and Trunk: Low Rate of Wound Complications
- ClinicalTrials.gov ID
- NCT02785692
- Acronym / sponsor ID
- 2015-00100
- Conditions
- Sarcoma
- Keywords
- soft tissue sarcoma, IMRT and sarcoma, preoperative highly conformal radiation therapy, soft tissue sarcoma and wound healing, postoperative complications, treatment tolerance of soft tissue IMRT
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator has left the Institution
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- Jan 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 30 May 2016 (estimated)
- 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.
Postoperative wound healing complications following preoperative radiotherapy represent a severe problem in the treatment of malignant soft tissue tumors, and are reported to be 34% and more. The literature discusses intensely the advantages and disadvantages of this multimodal treatment concept and there are different opinions. The Canadian prospective randomized NCIC SR2 trial showed increased wound complication rates in the study arm receiving preoperative radiation. The Sarcoma Center Zurich pursues mainly this treatment concept and the results shall now be analysed and published. The approach is to show that not only the complication rates are comparable to international bench marks, but also the (still intermediate time) local control rates.
Detailed description
Introduction: The Canadian prospective randomized NCIC SR2 trial tested the sequence of radiation and surgery for soft tissue sarcoma of the extremities. Similar disease control rates following pre- versus postoperative non-intensity modulated radiation therapy (non-IMRT) was found, with increased wound complications (17% vs 35%) in the preoperative radiation arm, [95% CI 5-30], p=0·01).
The investigators assessed a single center preoperative IMRT (or IMRT-equivalent highly conformal three dimensional conventional RT (3DcRT)) cohort with respect to the wound complication rate (WCR). The hypothesis was that a lower WCR rate was achieved in the era of IMRT as compared to the non-IMRT era when the Canadian Trial was conducted.
Methods: 67 consecutive patients irradiated with 50Gy in 25 fractions between 3/2008-3/2016 with preoperative IMRT (n=48, 72%) or highly conformal IMRT-equivalent 3DcRT dose distribution (n=19, 28%) were assessed. All patients were previously discussed at the weekly interdisciplinary sarcoma board of the Sarcoma Center Zurich.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined Radiation/ Surgery | – | Radiation: RadiationAll patients treated with combined radiotherapy and surgery at Balgrist University Hospital and University Hospital Zurich |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 67 patients with histological proven malignant soft tissue sarcomas who underwent preoperative radiotherapy followed by surgical tumor resection
Key inclusion criteria (3 listed)
- Patients with a malignant soft tissue tumour
- Patients who underwent preoperative radiotherapy at the department of radiation oncology, University Hospital Zurich (USZ)
- Surgical treatment at Balgrist University Hospital between 2007 and 2016
Key exclusion criteria (4 listed)
- Vulnerability
- Previous chemotherapy
- Previous radiotherapy on the affected site
- Patient's wish
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 |
|---|---|---|
| Radiationpreoperative Radiotherapy/ IMRT | Radiation | Combined Radiation/ Surgery |
Primary outcome
Major and minor wound healing complications
Time frame: through study completion, minimum 6 weeks post surgery
2 secondary outcomes
Local and metastatic disease control based on imaging such as CT scans and MRI
Time frame: maximum 10 years post surgery
Overall survival at the latest point of follow- up
Time frame: maximum 10 years post surgery
Results and safety
The study was stopped early (reason given: Principal Investigator has left the Institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Bruno Fuchs, Prof. MD PhD study chair
Balgrist University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, run by Balgrist University Hospital at 2 sites in Switzerland.
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: stopped early, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
The study was stopped early (reason given: Principal Investigator has left the Institution). 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?
Major and minor wound healing complications (time frame: through study completion, minimum 6 weeks post surgery). 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 2 Oct 2018.