Radical Resection and HIPEC for Recurrent Retroperitoneal Sarcoma

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Radical Resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of High Risk Recurrent Retroperitoneal Sarcoma

Conditions
-----------------
Retroperitoneal Sarcoma

Intervention / Treatment
-----------------
* Drug: Doxorubicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Disease Characteristics Histologically proven soft tissue sarcoma of one of following high-risk groups: Tumours with grade 2 or 3 histology Size more than or equal to 5cm Extracompartmental and deep extension Local recurrence of primary tumour Inadequate surgical excision of previously operated on tumour Proven diagnosis of recurrent retroperitoneal sarcoma confirmed by imaging modality and/ or intraoperative biopsy Patient Characteristics Age: ≥21 years old Performance status: ECOG 0-1 Normal haematological, hepatic, coagulation, renal and electrolyte profiles Normal left ventricular ejection fraction Not pregnant or nursing Exclusion Criteria: Patient is medically unfit for surgery due to concurrent medical comorbidities. Any medical or psychiatric condition(s) which would preclude informed consent. Patient is pregnant or nursing.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radical Resection and HIPEC<br> | Drug: Doxorubicin<br>* Immediately after resection, 15mg/m2 doxorubicin will be administered by peritoneal perfusion for 60 minutes and then drained.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-related adverse events | To evaluate chemotherapy toxicity and unforeseen acute and late complications associated with the treatment | From time of resection to one year post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence-free survival | 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 | From time of resection until first occurrence of disease recurrence, up to 3 years | 
| Overall survival | To determine if the introduction of radical surgery and HIPEC would improve the overall survival of patients as compared to current treatment strategies | From time of resection to death from any cause, up to 3 years |