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Radical Resection and HIPEC for Recurrent Retroperitoneal Sarcoma

Primary Purpose

Retroperitoneal Sarcoma

Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Doxorubicin
Sponsored by
National Cancer Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retroperitoneal Sarcoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Centre Singapore

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radical Resection and HIPEC

Arm Description

Outcomes

Primary Outcome Measures

Incidence of treatment-related adverse events
To evaluate chemotherapy toxicity and unforeseen acute and late complications associated with the treatment

Secondary Outcome Measures

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
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

Full Information

First Posted
January 2, 2019
Last Updated
October 9, 2023
Sponsor
National Cancer Centre, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT03792867
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 23, 2018 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Centre, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retroperitoneal Sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radical Resection and HIPEC
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Immediately after resection, 15mg/m2 doxorubicin will be administered by peritoneal perfusion for 60 minutes and then drained.
Primary Outcome Measure Information:
Title
Incidence of treatment-related adverse events
Description
To evaluate chemotherapy toxicity and unforeseen acute and late complications associated with the treatment
Time Frame
From time of resection to one year post-surgery
Secondary Outcome Measure Information:
Title
Local recurrence-free survival
Description
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
Time Frame
From time of resection until first occurrence of disease recurrence, up to 3 years
Title
Overall survival
Description
To determine if the introduction of radical surgery and HIPEC would improve the overall survival of patients as compared to current treatment strategies
Time Frame
From time of resection to death from any cause, up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnny Ong, MD, PhD
Organizational Affiliation
National Cancer Centre, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Radical Resection and HIPEC for Recurrent Retroperitoneal Sarcoma

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