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NCT04213794 · ClinicalTrials.gov registry record · Early Phase 1
Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for Abdominal for Pelvic Tumors in Pediatric Patients
A Early Phase 1 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 2
- Enrollment target
NCT04213794: Clinical Trial Early Phase 1 study, sponsored by Mayo Clinic.
NCT04213794 is a Early Phase 1 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 2 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04213794, a Early Phase 1 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
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 Outcome
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.
Interventions
- DRUG Cisplatin
- DRUG Doxorubicin
- PROCEDURE Cytoreductive Surgery
- DRUG Hyperthermic Intraperitoneal Chemotherapy
- DRUG Sodium Thiosulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2019-11-08 |
| Est. Completion | 2024-10-03 |
| Phase | Early Phase 1 |
Why NCT04213794 stopped before completion
NCT04213794 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT04213794 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04213794 about?
NCT04213794 is a clinical study titled "Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for Abdominal for Pelvic Tumors in Pediatric Patients". 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-perit...
What is the current status of trial NCT04213794?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 2 participants. The study started on 2019-11-08. Estimated completion is 2024-10-03.
What interventions are being tested in trial NCT04213794?
The interventions under investigation include: Cisplatin (DRUG), Doxorubicin (DRUG), Cytoreductive Surgery (PROCEDURE), Hyperthermic Intraperitoneal Chemotherapy (DRUG), Sodium Thiosulfate (DRUG).
Who is sponsoring clinical trial NCT04213794?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04213794's enrollment target sits among peer trials
2 1973rd of 2000 higher than 16 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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