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NCT03800693 · ClinicalTrials.gov registry record · Phase 2
2 Versus 6 Hour Oxaliplatin Infusions in Patients With Gastrointestinal Cancers
A Phase 2 study of Malignant Digestive System Neoplasm, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT03800693: Recruiting Phase 2 study of Malignant Digestive System Neoplasm, sponsored by Emory University.
NCT03800693 is a Phase 2 study of Malignant Digestive System Neoplasm that is actively recruiting participants, run by Emory University. The registered enrollment target is 60 participants, below the 685-participant average among 11 other Malignant Digestive System Neoplasm trials with a reported enrollment target (91% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03800693, a Phase 2 study of Malignant Digestive System Neoplasm, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial studies how well giving oxaliplatin over 6 hours works in treating nerve damage in patients with gastrointestinal cancers. Oxaliplatin can cause side effects such as nerve damage that may delay or reduce the dose of oxaliplatin. Giving oxaliplatin over a longer period of time (6 hours) may prevent or delay the development of nerve damage, which may keep patients on standard doses of chemotherapy longer, without having to delay treatment.
Primary Outcome
The EORTC-CIPN-20 sub-scales will be computed according to the standard scoring algorithm and then transformed to a 0 to 100 scale, where high scores mean less symptom burden. The primary outcome measure of difference in sensory scores of the two groups between baseline and the initiation of cycle 4 will be the driver of the analysis.
Conditions Studied
Interventions
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Oxaliplatin
Study Locations (3)
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-03-14 |
| Est. Completion | 2026-09-17 |
| Phase | Phase 2 |
What NCT03800693 shows while recruiting
NCT03800693 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 685-participant average among 11 other Malignant Digestive System Neoplasm trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Malignant Digestive System Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Fluorouracil is the first listed.
NCT03800693 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT03800693 about?
NCT03800693 is a clinical study titled "2 Versus 6 Hour Oxaliplatin Infusions in Patients With Gastrointestinal Cancers". This phase II trial studies how well giving oxaliplatin over 6 hours works in treating nerve damage in patients with gastrointestinal cancers. Oxaliplatin can cause side effects such as nerve damage that may delay or reduce the dose of oxaliplatin. Giving oxaliplatin over a longer period of time (6 ...
What is the current status of trial NCT03800693?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2019-03-14. Estimated completion is 2026-09-17.
What conditions does trial NCT03800693 study?
This clinical trial studies the following conditions: Malignant Digestive System Neoplasm.
What interventions are being tested in trial NCT03800693?
The interventions under investigation include: Fluorouracil (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG).
Who is sponsoring clinical trial NCT03800693?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03800693 being conducted?
This trial has 3 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Digestive System Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03800693's enrollment target sits among peer trials
60 7th of 11 higher than 4 of 11 other Malignant Digestive System Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Digestive System Neoplasm 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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