- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06612671
Treatment Outcomes of Retroperitoneal Sarcoma
September 22, 2024 updated by: Taichung Veterans General Hospital
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taichung, Taiwan
- Taichung Veterans General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- the patient who have retroperitoneal maliganacy and receive complete tumor excision in our hospital
Exclusion Criteria:
- the patient did not receive complete tumor excision in our hospital
- the pathological report yielded not malignancy tumor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall survival
Time Frame: The proportion of patients still alive at 1 year, 3 years, and 5 years after treatment.
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After treatment, patients will undergo long-term follow-up to record their survival status.
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The proportion of patients still alive at 1 year, 3 years, and 5 years after treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Progression defined as local, regional, or distant metastasis
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The rates of local recurrence, regional recurrence, or distant metastasis at 1 year, 3 years, and 5 years after treatment.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The resectability of preoperative embolization
Time Frame: From the start of preoperative evaluations to the day of surgery, it typically spans 7 days.
|
Preoperative embolization for assessing resectability combines radiology, angiography, and transcatheter arterial embolization (TAE).
Initially, imaging techniques such as X-rays or CT scans are used to understand the characteristics of the lesions.
Then, angiography is employed to observe the tumor's blood supply.
Finally, TAE not only evaluates the vascular supply to the tumor but also helps reduce its size through embolization, enhancing resectability.
The comprehensive results of these assessments contribute to developing a safe and effective surgical plan.
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From the start of preoperative evaluations to the day of surgery, it typically spans 7 days.
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The value of eGFR in renal function
Time Frame: Period from date before surgery to the date one year after suregry
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eGFR is an important biomarker used to assess kidney function and monitor renal health.
It represents the volume of blood filtered by the glomeruli per minute, typically expressed in milliliters per minute (mL/min).
A venous blood sample will be collected and analyzed in the laboratory to determine the value.
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Period from date before surgery to the date one year after suregry
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Radiation-Oncology Department Liu, M.D., Department of Radiation-Oncology, Taichung Veterans General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Actual)
July 1, 2024
Study Completion (Estimated)
September 30, 2025
Study Registration Dates
First Submitted
September 9, 2023
First Submitted That Met QC Criteria
September 22, 2024
First Posted (Actual)
September 25, 2024
Study Record Updates
Last Update Posted (Actual)
September 25, 2024
Last Update Submitted That Met QC Criteria
September 22, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE23365A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
I would like to share after the paper publish.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Retroperitoneal Sarcoma
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David Liebner, MDWithdrawnLocally Advanced Leiomyosarcoma | Metastatic Leiomyosarcoma | Unresectable Leiomyosarcoma | Stage III Retroperitoneal Sarcoma AJCC v8 | Stage IIIA Retroperitoneal Sarcoma AJCC v8 | Stage IIIB Retroperitoneal Sarcoma AJCC v8 | Stage IV Retroperitoneal Sarcoma AJCC v8United States
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