Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03792867
Other study ID # 2017/2012/B
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 23, 2018
Est. completion date March 31, 2024

Study information

Verified date October 2023
Source National Cancer Centre, Singapore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 5
Est. completion date March 31, 2024
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Singapore National Cancer Centre Singapore Singapore

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT03838718 - REtroperitoneal SArcoma Registry: an International Prospective Initiative
Enrolling by invitation NCT05844813 - Neoadjuvant Chemotherapy Combined With Targeted Treatment in High-risk Retroperitoneal Sarcoma Phase 4
Terminated NCT00901836 - Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma N/A
Completed NCT05044624 - Retroperıtoneal Soft-Tıssue Sarcomas N/A
Active, not recruiting NCT04189783 - Repeat or Single Quadratus Lumborum Block for the Reduction of Opioid Prescriptions After Surgery in Retroperitoneal Sarcoma Patients ("RESQU-SARC" Trial) Phase 2
Completed NCT04225494 - Perioperative Residual Adrenal Function After Extended Resection for Retroperitoneal Soft Tissue Sarcomas
Not yet recruiting NCT06025747 - Evaluation of Abemaciclib and Radiation Therapy Before Surgery for the Treatment of High-Risk Adipocytic Retroperitoneal Sarcoma Phase 1
Active, not recruiting NCT04224948 - The PET- Retroperitoneal Sarcoma Study N/A
Recruiting NCT04031677 - Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma Phase 3
Recruiting NCT05224934 - Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma Phase 2
Completed NCT03877588 - Nutritional Status in Retroperitoneal Sarcoma. N/A
Completed NCT02384473 - Real-Time Contrast-Enhanced Ultrasonography and Shear Wave Elastography in Predicting Treatment Response in Patients With Soft Tissue Sarcoma Early Phase 1
Withdrawn NCT05302570 - Neoadjuvant Short-course Hypofractionated PBT for Non-metastatic RPS Phase 2
Recruiting NCT01659203 - Proton or Photon RT for Retroperitoneal Sarcomas Phase 1/Phase 2
Recruiting NCT05631379 - Influence of Nutritional Status on Oncologic and Operative Outcome in Patients Operated for Retroperitoneal Sarcoma
Recruiting NCT06327477 - Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for the Treatment of Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma Phase 1/Phase 2