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NCT01197664 · ClinicalTrials.gov registry record · Phase 1
Paricalcitol, Fluorouracil, and Radiation Therapy in Treating Patients With Rectal Cancer That Can Be Removed in Surgery
A Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01197664: Clinical Trial Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT01197664 is a Phase 1 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01197664, a Phase 1 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This randomized pilot clinical trial studies the side effects of giving paricalcitol together with fluorouracil and radiation therapy in treating patients with rectal cancer that can be removed in surgery. Paricalcitol may help rectal cancer cells become more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. It not yet known if chemotherapy and radiation therapy are more effective with or without paricalcitol in treating rectal cancer
Primary Outcome
Calcium levels will be noted on a weekly basis during chemoradiotherapy and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Interventions
- OTHER laboratory biomarker analysis
- DRUG fluorouracil
- RADIATION radiation therapy
- DRUG paricalcitol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2010-08 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
Why NCT01197664 stopped before completion
NCT01197664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01197664 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01197664 about?
NCT01197664 is a clinical study titled "Paricalcitol, Fluorouracil, and Radiation Therapy in Treating Patients With Rectal Cancer That Can Be Removed in Surgery". This randomized pilot clinical trial studies the side effects of giving paricalcitol together with fluorouracil and radiation therapy in treating patients with rectal cancer that can be removed in surgery. Paricalcitol may help rectal cancer cells become more like normal cells, and to grow and sprea...
What is the current status of trial NCT01197664?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2010-08. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01197664?
The interventions under investigation include: laboratory biomarker analysis (OTHER), fluorouracil (DRUG), radiation therapy (RADIATION), paricalcitol (DRUG).
Who is sponsoring clinical trial NCT01197664?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01197664's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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