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NCT00707278 · ClinicalTrials.gov registry record · Phase 1

Radiation Therapy and Capecitabine/Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma

A Phase 1 study, sponsored by University of Utah.

Completed
Registry status
Phase 1
Development phase
13
Enrollment target

NCT00707278 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 13 participants.

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The verdict

NCT00707278, a Phase 1 study, has completed, sponsored by University of Utah.

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

The study is a prospective phase I trial of radiation therapy concurrent with capecitabine and oxaliplatin chemotherapy in the treatment of locally advanced pancreas adenocarcinoma. Eligibility criteria include pathologically confirmed, non-metastatic adenocarcinoma of the pancreas that is surgically unresectable. Patients will undergo radiation therapy (28 treatments of 1.8 Gy for a total of 50.4 Gy) concurrent with capecitabine and oxaliplatin chemotherapy. The primary objective of the study is to determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy with or without surgery in this patient population. Secondary objectives of the study are to determine the tumor response rate, survival rate, local control rate and the rate of distant metastases following capecitabine, oxaliplatin, and radiation therapy with or without surgery and to determine the rate at which patients with unresectable disease become resectable.

Interventions

  • DRUG Capecitabine
  • DRUG Oxaliplatin
  • RADIATION Radiation Therapy

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2005-09
Est. Completion 2011-08
Phase Phase 1

Sponsor

University of Utah

818 total trials

What the Registry Record Tells You About NCT00707278

The ClinicalTrials.gov registry entry for NCT00707278 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Capecitabine is the first listed.

NCT00707278 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00707278 about?

NCT00707278 is a clinical study titled "Radiation Therapy and Capecitabine/Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma". The study is a prospective phase I trial of radiation therapy concurrent with capecitabine and oxaliplatin chemotherapy in the treatment of locally advanced pancreas adenocarcinoma. Eligibility criteria include pathologically confirmed, non-metastatic adenocarcinoma of the pancreas that is surgicall...

What is the current status of trial NCT00707278?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2005-09. Estimated completion is 2011-08.

What interventions are being tested in trial NCT00707278?

The interventions under investigation include: Capecitabine (DRUG), Oxaliplatin (DRUG), Radiation Therapy (RADIATION).

Who is sponsoring clinical trial NCT00707278?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.