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NCT03330028 · ClinicalTrials.gov registry record · Phase 1
Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT03330028: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT03330028 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03330028, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of paclitaxel that can be given as hyperthermic intraperitoneal chemotherapy (HIPEC) to patients with gastric or gastroesophageal cancer. HIPEC is a system in which heated chemotherapy is delivered directly inside the abdomen during surgery. In this study, paclitaxel is being combined with mitomycin and cisplatin to see if this study drug combination can help to control the disease. This is an investigational study. Mitomycin, cisplatin, and paclitaxel are FDA-approved and commercially available for the treatment of gastric and gastroesophageal cancer. It is investigational to give these drugs by HIPEC. The study doctor can describe how the study drugs and HIPEC are designed to work. Up to 48 participants will be enrolled in this study. All will take part at MD Anderson.
Primary Outcome
MTD selected based on isotonic regression as specified per methods by Liu and Yuan.
Interventions
- DRUG Cisplatin
- DRUG Dexamethasone
- DRUG Mitomycin C
- DRUG Diphenhydramine
- DRUG Famotidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2017-10-27 |
| Est. Completion | 2023-04-18 |
| Phase | Phase 1 |
What the finished NCT03330028 record still lists
NCT03330028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT03330028 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03330028 about?
NCT03330028 is a clinical study titled "Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology". The goal of this clinical research study is to find the highest tolerable dose of paclitaxel that can be given as hyperthermic intraperitoneal chemotherapy (HIPEC) to patients with gastric or gastroesophageal cancer. HIPEC is a system in which heated chemotherapy is delivered directly inside the abd...
What is the current status of trial NCT03330028?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2017-10-27. Estimated completion is 2023-04-18.
What interventions are being tested in trial NCT03330028?
The interventions under investigation include: Cisplatin (DRUG), Dexamethasone (DRUG), Mitomycin C (DRUG), Diphenhydramine (DRUG), Famotidine (DRUG).
Who is sponsoring clinical trial NCT03330028?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03330028's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 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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