Radical Resection and HIPEC for Recurrent Retroperitoneal Sarcoma

Retroperitoneal Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03792867
• Other study ID #: 2017/2012/B
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 23, 2018
• Est. completion date: March 31, 2024

Study information

• Verified date: October 2023
• Source: National Cancer Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: March 31, 2024
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Retroperitoneal Sarcoma
• Sarcoma

Intervention

Drug:
• Doxorubicin
Immediately after resection, 15mg/m2 doxorubicin will be administered by peritoneal perfusion for 60 minutes and then drained.

Locations

Country	Name	City	State
Singapore	National Cancer Centre Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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