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NCT01516216 · ClinicalTrials.gov registry record · Phase 2
Study of Vitamin D in Untreated Metastatic Colorectal Cancer
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 139
- Enrollment target
NCT01516216: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT01516216 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 139 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01516216, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 139 participants
- Enrollment target
Study Summary
This is a prospective, randomized, double-blind phase II trial to evaluate the efficacy and safety of two doses of vitamin D supplementation in combination with standard chemotherapy in participants with previously-untreated metastatic colorectal adenocarcinoma.
Primary Outcome
Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesio
Interventions
- DIETARY_SUPPLEMENT Vitamin D
- DRUG FOLFOX + bevacizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2012-04-13 |
| Est. Completion | 2019-11-09 |
| Phase | Phase 2 |
What the finished NCT01516216 record still lists
NCT01516216 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Vitamin D is the first listed.
NCT01516216 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01516216 about?
NCT01516216 is a clinical study titled "Study of Vitamin D in Untreated Metastatic Colorectal Cancer". This is a prospective, randomized, double-blind phase II trial to evaluate the efficacy and safety of two doses of vitamin D supplementation in combination with standard chemotherapy in participants with previously-untreated metastatic colorectal adenocarcinoma.
What is the current status of trial NCT01516216?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 139 participants. The study started on 2012-04-13. Estimated completion is 2019-11-09.
What interventions are being tested in trial NCT01516216?
The interventions under investigation include: Vitamin D (DIETARY_SUPPLEMENT), FOLFOX + bevacizumab (DRUG).
Who is sponsoring clinical trial NCT01516216?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01516216's enrollment target sits among peer trials
139 525th of 2000 higher than 1,476 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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