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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 is a Phase 1 study that has completed, run by Virginia Commonwealth University. The registered enrollment target is 14 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02270606
The ClinicalTrials.gov registry entry for NCT02270606 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which oxaliplatin is the first listed.
NCT02270606 reports 0 study locations.
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.
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