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NCT03300609 · ClinicalTrials.gov registry record · Phase 3
5-FU Based Maintenance Therapy in RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX Plus Panitumumab
A Phase 3 study, sponsored by University of Southern California.
- Terminated
- Registry status
- Phase 3
- Development phase
- 4
- Enrollment target
NCT03300609: Clinical Trial Phase 3 study, sponsored by University of Southern California.
NCT03300609 is a Phase 3 study that was terminated before completion, run by University of Southern California. The registered enrollment target is 4 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03300609, a Phase 3 study, was terminated before completion, sponsored by University of Southern California.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 4 participants
- Enrollment target
Study Summary
This randomized trial studies how well panitumumab, leucovorin calcium, and fluorouracil after combination chemotherapy and panitumumab induction work in treating patients with RAS wild type colorectal cancer that has spread from where it started to nearby tissue or lymph nodes or other places in the body or cannot be removed by surgery. Monoclonal antibodies, such as panitumumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, 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. Giving panitumumab, leucovorin calcium, and fluorouracil after combination chemotherapy and panitumumab induction may work better in treating patients with colorectal cancer.
Primary Outcome
Disease progression will be determined by comparing tumor measurement during maintenance therapy to baseline measurement before starting maintenance treatment using Response Evaluation Criteria in Solid Tumors 1.1. will be conducted based on the intent-to-treat population from the time of randomization.
Interventions
- DRUG Capecitabine
- DRUG Fluorouracil
- DRUG Oxaliplatin
- BIOLOGICAL Panitumumab
- DRUG Leucovorin Calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2018-02-27 |
| Est. Completion | 2019-10-03 |
| Phase | Phase 3 |
Why NCT03300609 stopped before completion
NCT03300609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which Capecitabine is the first listed.
NCT03300609 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03300609 about?
NCT03300609 is a clinical study titled "5-FU Based Maintenance Therapy in RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX Plus Panitumumab". This randomized trial studies how well panitumumab, leucovorin calcium, and fluorouracil after combination chemotherapy and panitumumab induction work in treating patients with RAS wild type colorectal cancer that has spread from where it started to nearby tissue or lymph nodes or other places in th...
What is the current status of trial NCT03300609?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 4 participants. The study started on 2018-02-27. Estimated completion is 2019-10-03.
What interventions are being tested in trial NCT03300609?
The interventions under investigation include: Capecitabine (DRUG), Fluorouracil (DRUG), Oxaliplatin (DRUG), Panitumumab (BIOLOGICAL), Leucovorin Calcium (DRUG).
Who is sponsoring clinical trial NCT03300609?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03300609's enrollment target sits among peer trials
4 1998th of 2000 higher than 2 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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