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Radical Resection and HIPEC for Recurrent Retroperitoneal Sarcoma

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ClinicalTrials.gov Identifier: NCT03792867
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Centre, Singapore

Tracking Information
First Submitted Date  ICMJE January 2, 2019
First Posted Date  ICMJE January 3, 2019
Last Update Posted Date January 3, 2019
Actual Study Start Date  ICMJE July 23, 2018
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2019)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radical Resection and HIPEC for Recurrent Retroperitoneal Sarcoma
Official Title  ICMJE Radical Resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of High Risk Recurrent Retroperitoneal Sarcoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Retroperitoneal Sarcoma
Intervention  ICMJE Drug: Doxorubicin
Immediately after resection, 15mg/m2 doxorubicin will be administered by peritoneal perfusion for 60 minutes and then drained.
Study Arms  ICMJE Experimental: Radical Resection and HIPEC
Intervention: Drug: Doxorubicin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 2, 2019)		 50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Melissa Teo, MD +65 6436 8000 melissa.teo.c.c@singhealth.com.sg
Contact: Johnny Ong, MD, PhD +65 6436 8000 johnny.ong.c.a@singhealth.com.sg
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03792867
Other Study ID Numbers  ICMJE 2017/2012/B
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National Cancer Centre, Singapore
Study Sponsor  ICMJE National Cancer Centre, Singapore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Melissa Teo, MD National Cancer Centre, Singapore
Principal Investigator: Johnny Ong, MD, PhD Laboratory of Applied Human Genetics, National Cancer Centre Singapore
PRS Account National Cancer Centre, Singapore
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP