Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for Abdominal for Pelvic Tumors in Pediatric Patients
Public ClinicalTrials.gov record NCT04213794. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04213794
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Early Phase 1
- Enrollment
- 2 participants
Conditions and interventions
Conditions
- Malignant Abdominal Neoplasm
- Malignant Pelvic Neoplasm
- Recurrent Colon Carcinoma
- Recurrent Desmoplastic Small Round Cell Tumor
- Recurrent Fallopian Tube Carcinoma
- Recurrent Gastric Carcinoma
- Recurrent Liposarcoma
- Recurrent Malignant Mesothelioma
- Recurrent Ovarian Carcinoma
- Recurrent Primary Peritoneal Carcinoma
- Recurrent Rectal Carcinoma
- Recurrent Rhabdomyosarcoma
- Recurrent Sarcoma
- Refractory Colon Carcinoma
- Refractory Desmoplastic Small Round Cell Tumor
- Refractory Fallopian Tube Carcinoma
- Refractory Gastric Carcinoma
- Refractory Liposarcoma
- Refractory Malignant Mesothelioma
- Refractory Ovarian Carcinoma
- Refractory Primary Peritoneal Carcinoma
- Refractory Rectal Carcinoma
- Refractory Rhabdomyosarcoma
- Refractory Sarcoma
- Resectable Liposarcoma
- Resectable Malignant Mesothelioma
- Resectable Sarcoma
Interventions
- Cisplatin Drug
- Cytoreductive Surgery Procedure
- Doxorubicin Drug
- Hyperthermic Intraperitoneal Chemotherapy Drug
- Sodium Thiosulfate Drug
- Computed Tomography Procedure
- Magnetic Resonance Imaging Procedure
- Positron Emission Tomography Procedure
- Biospecimen Collection Procedure
Drug · Procedure
Eligibility (public fields only)
- Age range
- 1 Year to 25 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 7, 2019
- Primary completion
- Mar 3, 2024
- Completion
- Oct 2, 2024
- Last update posted
- Feb 19, 2025
2019 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04213794, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 19, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04213794 live on ClinicalTrials.gov.