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NCT01198548 · ClinicalTrials.gov registry record · Phase 2

High-Dose Cholecalciferol in Treating Patients Receiving Combination Chemotherapy and Bevacizumab as First-Line Therapy For Metastatic Colorectal Cancer

A Phase 2 study, sponsored by Roswell Park Cancer Institute.

Terminated
Registry status
Phase 2
Development phase
10
Enrollment target

NCT01198548: Clinical Trial Phase 2 study, sponsored by Roswell Park Cancer Institute.

NCT01198548 is a Phase 2 study that was terminated before completion, run by Roswell Park Cancer Institute. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01198548, a Phase 2 study, was terminated before completion, sponsored by Roswell Park Cancer Institute.

TERMINATED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

This phase II trial is studying how well giving high-dose cholecalciferol works in treating patients receiving combination chemotherapy and bevacizumab as first-line therapy for metastatic colorectal cancer. Cholecalciferol during treatment may delay the development of colorectal cancer. 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 or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving cholecalciferol together with combination chemotherapy and monoclonal antibody therapy may be an effective treatment for colorectal cancer

Primary Outcome

The estimated distributions of PFS will be obtained using the product-limit based Kaplan-Meier method. The corresponding 95% confidence intervals for the estimated probability will be computed using the method proposed in Clopper and Pearson.

Interventions

  • DRUG oxaliplatin
  • DRUG fluorouracil
  • DRUG leucovorin calcium
  • BIOLOGICAL bevacizumab
  • DIETARY_SUPPLEMENT cholecalciferol

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2010-08
Est. Completion 2012-06
Phase Phase 2
Roswell Park Cancer Institute

365 total trials

Why NCT01198548 stopped before completion

NCT01198548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 5 interventions - of which oxaliplatin is the first listed.

NCT01198548 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01198548 about?

NCT01198548 is a clinical study titled "High-Dose Cholecalciferol in Treating Patients Receiving Combination Chemotherapy and Bevacizumab as First-Line Therapy For Metastatic Colorectal Cancer". This phase II trial is studying how well giving high-dose cholecalciferol works in treating patients receiving combination chemotherapy and bevacizumab as first-line therapy for metastatic colorectal cancer. Cholecalciferol during treatment may delay the development of colorectal cancer. Drugs used ...

What is the current status of trial NCT01198548?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2010-08. Estimated completion is 2012-06.

What interventions are being tested in trial NCT01198548?

The interventions under investigation include: oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin calcium (DRUG), bevacizumab (BIOLOGICAL), cholecalciferol (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01198548?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01198548's enrollment target sits among peer trials

10 1968th of 2000 higher than 12 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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Source: ClinicalTrials.gov NCT01198548, the US trial registry maintained by the National Library of Medicine. NCT01198548 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.