Retroperitoneal SarcomaNCT06612671
Treatment Outcomes of Retroperitoneal Sarcoma
An observational study of Retroperitoneal Sarcoma, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
Investigators tried condult a retrospective study to analysis the prognostic factors and oncological outcome analysis of Retroperitoneal Sarcoma treated in our high volume medical center. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Retroperitoneal Sarcoma
- What is being tested?
- tumor wide excision
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2023to 30 Sep 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patient who have retroperitoneal maliganacy and receive complete tumor excision in our hospital. The preoperative procedure including angiography or TAE, radiotherapy is allowed.
Who may be able to join
- the patient who have retroperitoneal maliganacy and receive complete tumor excision in our hospital
Who cannot join
- the patient did not receive complete tumor excision in our hospital
- the pathological report yielded not malignancy tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Factors and Oncological Outcome Analysis of Retroperitoneal Sarcoma
Investigators tried condult a retrospective study to analysis the prognostic factors and oncological outcome analysis of Retroperitoneal Sarcoma treated in our high volume medical center.
Read the detailed description
Retroperitoneal Sarcoma (RPS) which is a rare disease which incidence is 1.79/100,000. The treatment is difficult to due to it anatomy position which often invade to multiple organs and cause the complete surgical resection to be very complex and difficult. It was known to sacrifice one side kidney will improve the resection rate. To this days, successful surgical resection was still the gold standard that provide most benefit in overall survival. To reach that goal, pre-operative radiotherapy was applied to RPS which intended to achieve similar effect in rectal cancer for the down staging effect and improved the respectability but with limited benefit. Herein, investigators conducted this study to find the best way to achieve successful surgical resection and prognostic factor analysis.
- Conditions
- Retroperitoneal Sarcoma
- Being tested
- tumor wide excision
- Keywords
- Retroperitoneal Sarcoma, Surgery, Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumor wide excisionProcedure or surgery
Also called Radiation
patients received properative or post-operative radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
After treatment, patients will undergo long-term follow-up to record their survival status.
Measured: The proportion of patients still alive at 1 year, 3 years, and 5 years after treatment.
Secondary outcomes (1)
Progression free survival
Progression defined as local, regional, or distant metastasis
Measured: The rates of local recurrence, regional recurrence, or distant metastasis at 1 year, 3 years, and 5 years after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Oct 2023
- Primary completion1 Jul 2024
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retroperitoneal SarcomaStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Radiation-Oncology Department Liu, M.D., Principal investigator, Department of Radiation-Oncology, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612671
- Sponsor's protocol ID
- CE23365A
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2023
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I would like to share after the paper publish.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors and Oncological Outcome Analysis of Retroperitoneal Sarcoma
- ClinicalTrials.gov ID
- NCT06612671
- Acronym / sponsor ID
- CE23365A
- Conditions
- Retroperitoneal Sarcoma
- Keywords
- Retroperitoneal Sarcoma, Surgery, Radiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 25 Sep 2024 (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.
Investigators tried condult a retrospective study to analysis the prognostic factors and oncological outcome analysis of Retroperitoneal Sarcoma treated in our high volume medical center.
Detailed description
Retroperitoneal Sarcoma (RPS) which is a rare disease which incidence is 1.79/100,000. The treatment is difficult to due to it anatomy position which often invade to multiple organs and cause the complete surgical resection to be very complex and difficult. It was known to sacrifice one side kidney will improve the resection rate. To this days, successful surgical resection was still the gold standard that provide most benefit in overall survival. To reach that goal, pre-operative radiotherapy was applied to RPS which intended to achieve similar effect in rectal cancer for the down staging effect and improved the respectability but with limited benefit. Herein, investigators conducted this study to find the best way to achieve successful surgical resection and prognostic factor analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patient who have retroperitoneal maliganacy and receive complete tumor excision in our hospital. The preoperative procedure including angiography or TAE, radiotherapy is allowed.
Key inclusion criteria (1 listed)
- the patient who have retroperitoneal maliganacy and receive complete tumor excision in our hospital
Key exclusion criteria (2 listed)
- the patient did not receive complete tumor excision in our hospital
- the pathological report yielded not malignancy tumor
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 |
|---|---|---|
| tumor wide excisionAlso: Radiationpatients received properative or post-operative radiotherapy | Procedure or surgery | – |
Primary outcome
Overall survival
Time frame: The proportion of patients still alive at 1 year, 3 years, and 5 years after treatment.
After treatment, patients will undergo long-term follow-up to record their survival status.
1 secondary outcome
Progression free survival
Time frame: The rates of local recurrence, regional recurrence, or distant metastasis at 1 year, 3 years, and 5 years after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: Undecided. I would like to share after the paper publish.
Related trials for Retroperitoneal Sarcoma
RecruitingObservational study
Retroperitoneal Tumor Registry
Retroperitoneal Neoplasms
Active, not recruitingPhase 2
Repeat or Single Quadratus Lumborum Block for the Reduction of Opioid Prescriptions After Surgery in Retroperitoneal Sarcoma Patients ("RESQU-SARC" Trial)
Retroperitoneal Sarcoma
RecruitingPhase 3
Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
Retroperitoneal Sarcoma, Liposarcoma
RecruitingPhase 1
A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for Liposarcomas
Retroperitoneal Sarcoma, Liposarcoma
RecruitingPhase 1/2
Proton or Photon RT for Retroperitoneal Sarcomas
Retroperitoneal Sarcoma
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.
Radiation-Oncology Department Liu, M.D. principal investigator
Department of Radiation-Oncology, Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retroperitoneal Sarcoma, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 1 inclusion and 2 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 25 Sep 2024. 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 Taiwan. 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?
Overall survival (time frame: The proportion of patients still alive at 1 year, 3 years, and 5 years after treatment.). 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 25 Sep 2024.