Radical Resection and HIPEC for Recurrent Retroperitoneal Sarcoma

NCT03792867 | Unknown

• 1 other identifier: 2017/2012/B
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Retroperitoneal Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Local recurrence-free survival

  From time of resection until first occurrence of disease recurrence, up to 3 years

• Overall survival

  From time of resection to death from any cause, up to 3 years

Study Arms (1)

Radical Resection and HIPEC

EXPERIMENTAL

Drug: Doxorubicin

Interventions

Doxorubicin DRUG

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

Radical Resection and HIPEC

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Centre Singapore

Singapore, 169610, Singapore

Location

Related Publications (1)

• Seo CJ, Tan JW, Farid M, Wong JSM, Soo KC, Chia CS, Ong CJ. Radical resection and hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of high risk recurrent retroperitoneal sarcoma-A pilot study in a tertiary Asian centre. PLoS One. 2024 Apr 4;19(4):e0300594. doi: 10.1371/journal.pone.0300594. eCollection 2024.

  PMID: 38574044 DERIVED

MeSH Terms

Interventions

Doxorubicin

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Johnny Ong, MD, PhD

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 3, 2019
• Study Start: July 23, 2018
• Primary Completion: February 28, 2022
• Study Completion: March 31, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)