Clinical trial NCT03792867: Radical Resection and HIPEC for Recurrent Retroperitoneal Sarcoma
Official title: Radical Resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of High Risk Recurrent Retroperitoneal Sarcoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Retroperitoneal Sarcoma
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Disease Characteristics

   1. 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
   2. Local recurrence of primary tumour
   3. Inadequate surgical excision of previously operated on tumour
   4. Proven diagnosis of recurrent retroperitoneal sarcoma confirmed by imaging modality and/ or intraoperative biopsy
2. Patient Characteristics

   1. Age: ≥21 years old
   2. Performance status: ECOG 0-1
   3. Normal haematological, hepatic, coagulation, renal and electrolyte profiles
   4. Normal left ventricular ejection fraction
   5. Not pregnant or nursing

Exclusion Criteria:

1. Patient is medically unfit for surgery due to concurrent medical comorbidities.
2. Any medical or psychiatric condition(s) which would preclude informed consent.
3. Patient is pregnant or nursing.

Primary outcomes:
measure: Incidence of treatment-related adverse events
timeFrame: From time of resection to one year post-surgery
Secondary outcomes:
measure: Local recurrence-free survival
timeFrame: From time of resection until first occurrence of disease recurrence, up to 3 years
measure: Overall survival
timeFrame: From time of resection to death from any cause, up to 3 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Johnny Ong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: