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NCT01240304 · ClinicalTrials.gov registry record · Phase 2

A Phase II Study to Assess the Efficacy and Safety of Preoperative Chemo With Radiation Therapy for Patients With Borderline Unresectable Adenocarcinoma of the Pancreas

A Phase 2 study, sponsored by University of Arkansas.

Terminated
Registry status
Phase 2
Development phase
10
Enrollment target

NCT01240304: Clinical Trial Phase 2 study, sponsored by University of Arkansas.

NCT01240304 is a Phase 2 study that was terminated before completion, run by University of Arkansas. 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

NCT01240304, a Phase 2 study, was terminated before completion, sponsored by University of Arkansas.

TERMINATED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

The purpose of this phase II clinical trial study is to assess the resection rate among subjects who have been initially diagnosed with unresectable or borderline resectable pancreatic adenocarcinoma. This will be done by providing preoperative treatment that will include alternating cycles of chemotherapy and radiotherapy treatment. In addition, this clinical trial will assess the safety of preoperative chemotherapy with radiation therapy for subjects with unresectable or borderline resectable adenocarcinoma of the pancreatic head, assess margin-negative resection rates, disease-free survival, assess overall survival rates, and determine patterns of local and distant recurrence.

Primary Outcome

This will be determined by the tumor's response to the pre/post-operative treatment so that the tumor can be removed surgically.

Interventions

  • DRUG Gemcitabine
  • RADIATION Radiation therapy
  • PROCEDURE pancreaticoduodenectomy

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2010-11
Est. Completion 2019-10
Phase Phase 2
University of Arkansas

318 total trials

Why NCT01240304 stopped before completion

NCT01240304 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 3 interventions - of which Gemcitabine is the first listed.

NCT01240304 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01240304 about?

NCT01240304 is a clinical study titled "A Phase II Study to Assess the Efficacy and Safety of Preoperative Chemo With Radiation Therapy for Patients With Borderline Unresectable Adenocarcinoma of the Pancreas". The purpose of this phase II clinical trial study is to assess the resection rate among subjects who have been initially diagnosed with unresectable or borderline resectable pancreatic adenocarcinoma. This will be done by providing preoperative treatment that will include alternating cycles of chemo...

What is the current status of trial NCT01240304?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2010-11. Estimated completion is 2019-10.

What interventions are being tested in trial NCT01240304?

The interventions under investigation include: Gemcitabine (DRUG), Radiation therapy (RADIATION), pancreaticoduodenectomy (PROCEDURE).

Who is sponsoring clinical trial NCT01240304?

This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01240304'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 NCT01240304, the US trial registry maintained by the National Library of Medicine. NCT01240304 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.