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NCT01918644 · ClinicalTrials.gov registry record · Phase 1

Neoadjuvant SBRT With Concomitant Capecitabine in Resectable Pancreatic Cancer

A Phase 1 study, sponsored by University of Wisconsin, Madison.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target

NCT01918644: Completed Phase 1 study, sponsored by University of Wisconsin, Madison.

NCT01918644 is a Phase 1 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01918644, a Phase 1 study, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of stereotactic body radiation therapy when given together with capecitabine before surgery in treating patients with pancreatic cancer that can be removed by surgery. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving stereotactic body radiation therapy and capecitabine before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Primary Outcome

The number and percent of patients reporting adverse events (all, severe or worse, serious and related) will be quantified for each dose level.

Interventions

  • OTHER laboratory biomarker analysis
  • RADIATION stereotactic body radiation therapy
  • PROCEDURE therapeutic conventional surgery
  • DRUG capecitabine
  • PROCEDURE magnetic resonance imaging

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2014-04-08
Est. Completion 2022-04-26
Phase Phase 1
University of Wisconsin, Madison

1,039 total trials

What the finished NCT01918644 record still lists

NCT01918644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).

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

NCT01918644 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01918644 about?

NCT01918644 is a clinical study titled "Neoadjuvant SBRT With Concomitant Capecitabine in Resectable Pancreatic Cancer". This phase I trial studies the side effects and best dose of stereotactic body radiation therapy when given together with capecitabine before surgery in treating patients with pancreatic cancer that can be removed by surgery. Stereotactic body radiation therapy may be able to send x-rays directly to...

What is the current status of trial NCT01918644?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2014-04-08. Estimated completion is 2022-04-26.

What interventions are being tested in trial NCT01918644?

The interventions under investigation include: laboratory biomarker analysis (OTHER), stereotactic body radiation therapy (RADIATION), therapeutic conventional surgery (PROCEDURE), capecitabine (DRUG), magnetic resonance imaging (PROCEDURE).

Who is sponsoring clinical trial NCT01918644?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01918644's enrollment target sits among peer trials

21 1615th of 2000 higher than 372 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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Source: ClinicalTrials.gov NCT01918644, the US trial registry maintained by the National Library of Medicine. NCT01918644 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.