Radical Resection and HIPEC for Recurrent Retroperitoneal Sarcoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-23

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Radical Colorectal Resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Colorectal Cancer

NCT02830139

Malignant Neoplasm of Colorectum

COMPLETED PHASE2

Surgery With HIPEC in Treating Patients With a High Risk of Developing Colorectal Peritoneal Carcinomatosis

NCT02179489

Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4 Peritoneal Carcinomatosis

COMPLETED NA

Oncologic Impact of Splenectomy-omitting Radical Pancreatectomy in Well-selected Left-sided Pancreatic Cancer

NCT01875198

Left-sided Pancreatic Cancer Ductal Adenocarcinoma

TERMINATED NA

Surgical Resection Combined With Intraperitoneal Hyperthermic Chemotherapy

NCT06247293

Hyperthermic Intraperitoneal Chemotherapy Hepatocellular Carcinoma Ruptured Liver

UNKNOWN

Prophylactic HIPEC for Colorectal Cancers at High Risk of Developing Peritoneal Metastases

NCT03422432

Colorectal Cancer Peritoneal Metastases

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retroperitoneal Sarcoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Radical Resection and HIPEC

Group Type EXPERIMENTAL

Doxorubicin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Doxorubicin

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No