Radical Resection and HIPEC for Recurrent Retroperitoneal Sarcoma
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|ClinicalTrials.gov Identifier: NCT03792867|
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Retroperitoneal sarcoma is a rare cancer that accounts for 15% of soft tissue sarcomas and affects many young people. In approximately 50% of patients, the tumour will reappear in the same area regardless of therapy. Current treatment involves radical resection; however, it does not significantly reduce recurrence rates or improve overall survival. Recurrent retroperitoneal sarcoma does not respond well to chemotherapy and prognosis is often guarded. One of the main challenges in the surgical treatment of this disease is the ability to accurately identify the local extension of the disease and to prevent local recurrence.
At present, there are no options to prevent recurrence after surgery. In recent years, there has been increased interest in the use of combined radical surgery with heated intraperitoneal chemotherapy (HIPEC). Radical resection is defined as en-bloc resection of the tumour including but not limited to surrounding organ resection and normal fat. This is in combination with the use of HIPEC. HIPEC is the use of chemotherapy in the intraperitoneal cavity that is heated to 40 to 42 degree Celsius.
Surgery coupled with HIPEC has shown to reduce recurrence in colorectal cancer, appendiceal cancer and mesothelioma. We hypothesize that HIPEC when coupled with radical surgery will improve the overall outcomes of patients with retroperitoneal sarcomatosis. We hope to learn if this treatment approach will increase locoregional control to reduce recurrence rates and improve survival.
|Condition or disease||Intervention/treatment||Phase|
|Retroperitoneal Sarcoma||Drug: Doxorubicin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Radical Resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of High Risk Recurrent Retroperitoneal Sarcoma|
|Actual Study Start Date :||July 23, 2018|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
|Experimental: Radical Resection and HIPEC||
Immediately after resection, 15mg/m2 doxorubicin will be administered by peritoneal perfusion for 60 minutes and then drained.
- Incidence of treatment-related adverse events [ Time Frame: From time of resection to one year post-surgery ]To evaluate chemotherapy toxicity and unforeseen acute and late complications associated with the treatment
- Local recurrence-free survival [ Time Frame: From time of resection until first occurrence of disease recurrence, up to 3 years ]To determine if the introduction of radical surgery and HIPEC would improve the local recurrence-free survival of patients as compared to current treatment strategies
- Overall survival [ Time Frame: From time of resection to death from any cause, up to 3 years ]To determine if the introduction of radical surgery and HIPEC would improve the overall survival of patients as compared to current treatment strategies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792867
|Contact: Melissa Teo, MD||+65 6436 firstname.lastname@example.org|
|Contact: Johnny Ong, MD, PhD||+65 6436 email@example.com|
|National Cancer Centre Singapore||Recruiting|
|Singapore, Singapore, 169610|
|Contact: Melissa Teo, MD +65 6436 8000 firstname.lastname@example.org|
|Principal Investigator: Melissa Teo, MD|
|Sub-Investigator: Johnny Ong, MD, PhD|
|Principal Investigator:||Melissa Teo, MD||National Cancer Centre, Singapore|
|Principal Investigator:||Johnny Ong, MD, PhD||Laboratory of Applied Human Genetics, National Cancer Centre Singapore|