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NCT02270606 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Neoadjuvant Radiotherapy With 5-Fluorouracil for Rectal Cancer
A Phase 1 study, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT02270606: Completed Phase 1 study, sponsored by Virginia Commonwealth University.
NCT02270606 is a Phase 1 study that has completed, run by Virginia Commonwealth University. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02270606, a Phase 1 study, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of fluorouracil when given together with radiation therapy followed by combination chemotherapy before and after surgery in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, 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 more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving additional combination chemotherapy after surgery may kill any remaining tumor cells. Giving radiation therapy and fluorouracil followed by combination chemotherapy before and after surgery may be a better treatment for rectal cancer.
Primary Outcome
To determine the maximum tolerated dose of continuous infusional 5-Fluorouracil, up to a target dose of 200 mg/m\^2/day, given concurrently with short course radiation followed by neoadjuvant FOLFOX chemotherapy and planned surgical resection for locally advanced rectal cancer. Assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Interventions
- DRUG oxaliplatin
- PROCEDURE therapeutic conventional surgery
- RADIATION intensity-modulated radiation therapy
- DRUG fluorouracil
- DRUG leucovorin calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2014-12-04 |
| Est. Completion | 2021-05-13 |
| Phase | Phase 1 |
What the finished NCT02270606 record still lists
NCT02270606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 5 interventions - of which oxaliplatin is the first listed.
NCT02270606 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02270606 about?
NCT02270606 is a clinical study titled "Phase I Study of Neoadjuvant Radiotherapy With 5-Fluorouracil for Rectal Cancer". This phase I trial studies the side effects and best dose of fluorouracil when given together with radiation therapy followed by combination chemotherapy before and after surgery in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes. Radiation ...
What is the current status of trial NCT02270606?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2014-12-04. Estimated completion is 2021-05-13.
What interventions are being tested in trial NCT02270606?
The interventions under investigation include: oxaliplatin (DRUG), therapeutic conventional surgery (PROCEDURE), intensity-modulated radiation therapy (RADIATION), fluorouracil (DRUG), leucovorin calcium (DRUG).
Who is sponsoring clinical trial NCT02270606?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02270606's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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