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NCT01188109 · ClinicalTrials.gov registry record · Phase 2

Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of ERCC1 in Treatment Decision

A Phase 2 study, sponsored by Emory University.

Terminated
Registry status
Phase 2
Development phase
25
Enrollment target

NCT01188109: Clinical Trial Phase 2 study, sponsored by Emory University.

NCT01188109 is a Phase 2 study that was terminated before completion, run by Emory University. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01188109, a Phase 2 study, was terminated before completion, sponsored by Emory University.

TERMINATED
Registry status
Phase 2
Development phase
25 participants
Enrollment target

Study Summary

The purpose of this study is to investigate if the investigators can use a specific marker in the pancreatic tumor itself to determine which patients will benefit from receiving combination chemotherapy of gemcitabine and cisplatin after undergoing resection of a pancreatic cancer. The investigators will also investigate if there is any benefit to receiving both chemotherapy drugs as opposed to only gemcitabine after undergoing complete resection of the tumor.

Primary Outcome

Clinical data were prospectively collected. Staging was performed using 7th American Committee on Cancer criteria. Patients were followed by radiologic evaluation (CT or MRI) and carbohydrate antigen 19-9 (CA19-9) every 3 months for the first 3 years after resection to assess for recurrence. Subsequently, patients underwent imaging every 6 months.

Interventions

  • DRUG Cisplatin
  • DRUG Gemcitabine

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2010-07
Est. Completion 2015-07
Phase Phase 2
Emory University

1,208 total trials

Why NCT01188109 stopped before completion

NCT01188109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 2 interventions - of which Cisplatin is the first listed.

NCT01188109 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01188109 about?

NCT01188109 is a clinical study titled "Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of ERCC1 in Treatment Decision". The purpose of this study is to investigate if the investigators can use a specific marker in the pancreatic tumor itself to determine which patients will benefit from receiving combination chemotherapy of gemcitabine and cisplatin after undergoing resection of a pancreatic cancer. The investigator...

What is the current status of trial NCT01188109?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2010-07. Estimated completion is 2015-07.

What interventions are being tested in trial NCT01188109?

The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG).

Who is sponsoring clinical trial NCT01188109?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01188109's enrollment target sits among peer trials

25 1719th of 2000 higher than 245 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 NCT01188109, the US trial registry maintained by the National Library of Medicine. NCT01188109 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.