Radical Resection and HIPEC for Recurrent Retroperitoneal Sarcoma

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Retroperitoneal Sarcoma
• Intervention / Treatment: Drug: Doxorubicin

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johnny Ong, MD, PhD; Phone Number: +65 6436 8000; Email: johnny.ong.c.a@singhealth.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 169610
    • National Cancer Centre Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: National Cancer Centre, Singapore
• Investigators: Principal Investigator: Johnny Ong, MD, PhD, National Cancer Centre, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2018
• Primary Completion (Actual): February 28, 2022
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Doxorubicin
• Other Study ID Numbers: 2017/2012/B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No