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NCT02672098 · ClinicalTrials.gov registry record · Phase 1
Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer
A Phase 1 study, sponsored by Loma Linda University.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT02672098: Completed Phase 1 study, sponsored by Loma Linda University.
NCT02672098 is a Phase 1 study that has completed, run by Loma Linda University. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02672098, a Phase 1 study, has completed, sponsored by Loma Linda University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is a phase I prospective study with the primary objective to compare the efficacy and safety of Surgical cytoreduction (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in treatment of recurrent ovarian, primary peritoneal or fallopian tube cancers. Eligible patients consenting to this protocol will undergo their scheduled surgical procedure. After surgical cytoreduction to a residual disease ≤ 2.5 mm, a single dose of carboplatin (800 mg/m2) will be administered in normal saline via intraperitoneal hyperthermic perfusion using the closed-abdomen. HIPEC will be continued for 90 minutes in the hyperthermic phase (41°C-43°C). At 4-6 weeks after CRS, patients will go on to receive 6 cycles of standard IV platinum-based chemotherapy. The proportion of patients who are without evidence of recurrence will be assessed at 6, 9, 12 and 18 months after the day of surgery.
Primary Outcome
Surveillance CT Chest, abdomen and pelvis with IV and oral contrast and serum CA-125 levels will be obtained at 6 months after the day of surgery. Recurrence-free survival will be assessed using RECIST 1.1 guideline (version 1.1).
Interventions
- DRUG Carboplatin
- PROCEDURE Hyperthermic intraperitoneal chemotherapy (HIPEC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2016-07-14 |
| Est. Completion | 2023-04-19 |
| Phase | Phase 1 |
What the finished NCT02672098 record still lists
NCT02672098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Carboplatin is the first listed.
NCT02672098 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02672098 about?
NCT02672098 is a clinical study titled "Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer". This is a phase I prospective study with the primary objective to compare the efficacy and safety of Surgical cytoreduction (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in treatment of recurrent ovarian, primary peritoneal or fallopian tube cancers. Eligible patients consenting to thi...
What is the current status of trial NCT02672098?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2016-07-14. Estimated completion is 2023-04-19.
What interventions are being tested in trial NCT02672098?
The interventions under investigation include: Carboplatin (DRUG), Hyperthermic intraperitoneal chemotherapy (HIPEC) (PROCEDURE).
Who is sponsoring clinical trial NCT02672098?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02672098's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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