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Radical Resection and HIPEC for Recurrent Retroperitoneal Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03792867
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Information provided by (Responsible Party):
National Cancer Centre, Singapore

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.

Condition or disease Intervention/treatment Phase
Retroperitoneal Sarcoma Drug: Doxorubicin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radical Resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of High Risk Recurrent Retroperitoneal Sarcoma
Actual Study Start Date : July 23, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

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.

Primary Outcome Measures :
  1. Incidence of treatment-related adverse events [ Time Frame: From time of resection to one year post-surgery ]
    To evaluate chemotherapy toxicity and unforeseen acute and late complications associated with the treatment

Secondary Outcome Measures :
  1. Local recurrence-free survival [ Time Frame: From time of resection until first occurrence of disease recurrence, up to 3 years ]
    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

  2. Overall survival [ Time Frame: From time of resection to death from any cause, up to 3 years ]
    To determine if the introduction of radical surgery and HIPEC would improve the overall survival of patients as compared to current treatment strategies

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03792867

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Contact: Melissa Teo, MD +65 6436 8000
Contact: Johnny Ong, MD, PhD +65 6436 8000

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National Cancer Centre Singapore Recruiting
Singapore, Singapore, 169610
Contact: Melissa Teo, MD    +65 6436 8000   
Principal Investigator: Melissa Teo, MD         
Sub-Investigator: Johnny Ong, MD, PhD         
Sponsors and Collaborators
National Cancer Centre, Singapore
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Principal Investigator: Melissa Teo, MD National Cancer Centre, Singapore
Principal Investigator: Johnny Ong, MD, PhD Laboratory of Applied Human Genetics, National Cancer Centre Singapore

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Responsible Party: National Cancer Centre, Singapore Identifier: NCT03792867     History of Changes
Other Study ID Numbers: 2017/2012/B
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action