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Patients undergo cytoreduction. Patients also undergo HIPEC over 60 minutes consisting of doxorubicin and cisplatin. Patients then receive sodium thiosulfate IV over 12 hours. Patients also undergo CT scan, MRI or PET/CT scan and blood sample collection throughout study.

Undergo HIPEC with doxorubicin and cisplatin

Cytoreductive Surgery

Hyperthermic Intraperitoneal Chemotherapy

Sodium Thiosulfate

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Magnetic Resonance Imaging

Positron Emission Tomography

Biospecimen Collection

Clinical Trial Referral Office

Patricio C. Gargollo, M.D.

This early phase I trial studies how well heated intra-peritoneal chemotherapy with doxorubicin and cisplatin work for the treatment of abdominal or pelvic tumors that can be removed by surgery (resectable), does not respond to treatment (refractory), or has come back (recurrent). Heated intra-peritoneal chemotherapy is a procedure performed in combination with abdominal surgery for cancer that has spread to the abdomen. It involves the infusion of a heated chemotherapy solution that circulates into the abdominal cavity. Chemotherapy drugs, such as doxorubicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more cells.

PRIMARY OBJECTIVES:

I. To assess the feasibility of heated intra-peritoneal chemotherapy (HIPEC) with doxorubicin (DOXO) and cisplatin (CDDP) after surgical resection of pediatric pelvic and abdominal tumors.

II. To assess morbidity, hospital length of stay and peri-operative mortality outcomes for pediatric patients with intraperitoneal sarcoma undergoing hyperthermic intraperitoneal chemotherapy.

SECONDARY OBJECTIVE:

I. To assess complications and adverse events of HIPEC. II. Evaluate disease recurrence patterns: locoregional versus distant. III. Evaluate disease progression defined by radio-graphically visible nodules greater than 1.5 cm.

OUTLINE:

Patients undergo cytoreduction. Patients also undergo HIPEC over 60 minutes consisting of doxorubicin and cisplatin. Patients then receive sodium thiosulfate intravenously (IV) over 12 hours.

After completion of the study treatment, patients are followed every 6 months for 5 years.

Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for Abdominal for Pelvic Tumors in Pediatric Patients

A Prospective Study of Heated Intra-Peritoneal Chemotherapy (H.I.P.E.C.) With Doxorubicin and Cisplatin in Pediatric Patients With Pelvic and Abdominal Tumors. The TOAST IT Trial (Trial Of Adjuvant Surgical Treatment With Intraperitoneal Chemotherapy)

To assess the feasibility of heated intra-peritoneal chemotherapy (HIPEC) with doxorubicin (DOXO) and cisplatin (CDDP) after surgical resection of pediatric pelvic and abdominal tumors.

Will be estimated using the Kaplan-Meier method. Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging. Patient contact may be contacted by telephone.

Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging. Patient contact may be contacted by telephone.

Will be measured using the Clavien Dindo scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.

Will be tracked using NCI CTCAE version 5.

The PFS is defined as the time between initiation of protocol treatment and the first occurrence of disease. It will be defined radiologically.

Mayo Clinic

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for Abdominal for Pelvic Tumors in Pediatric Patients	NCT04213794	Malignant Abdom... Malignant Pelvi... Recurrent Colon... Recurrent Desmo... Recurrent Fallo... Recurrent Gastr... Recurrent Lipos... Recurrent Malig... Recurrent Ovari... Recurrent Prima... Recurrent Recta... Recurrent Rhabd... Recurrent Sarco... Refractory Colo... Refractory Desm... Refractory Fall... Refractory Gast... Refractory Lipo... Refractory Mali... Refractory Ovar... Refractory Prim... Refractory Rect... Refractory Rhab... Refractory Sarc... Resectable Lipo... Resectable Mali... Resectable Sarc...	Cisplatin Cytoreductive S... Doxorubicin Hyperthermic In... Sodium Thiosulf... Computed Tomogr... Magnetic Resona... Positron Emissi... Biospecimen Col...	1 Year - 25 Years	Mayo Clinic
Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for Abdominal for Pelvic Tumors in Pediatric Patients	NCT04213794	Malignant Abdom... Malignant Pelvi... Recurrent Colon... Recurrent Desmo... Recurrent Fallo... Recurrent Gastr... Recurrent Lipos... Recurrent Malig... Recurrent Ovari... Recurrent Prima... Recurrent Recta... Recurrent Rhabd... Recurrent Sarco... Refractory Colo... Refractory Desm... Refractory Fall... Refractory Gast... Refractory Lipo... Refractory Mali... Refractory Ovar... Refractory Prim... Refractory Rect... Refractory Rhab... Refractory Sarc... Resectable Lipo... Resectable Mali... Resectable Sarc...	Cisplatin Cytoreductive S... Doxorubicin Hyperthermic In... Sodium Thiosulf... Computed Tomogr... Magnetic Resona... Positron Emissi... Biospecimen Col...	1 Year - 25 Years	Mayo Clinic

Spots Global Cancer Trial Database for refractory desmoplastic small round cell tumor