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NCT00096070 · ClinicalTrials.gov registry record · Phase 2

Radiotherapy Combined With Oxaliplatin and Fluorouracil Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
50
Enrollment target

NCT00096070: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00096070 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00096070, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target

Study Summary

This phase II trial is studying how well giving radiation therapy together with oxaliplatin and fluorouracil followed by gemcitabine works in treating patients with locally advanced, unresectable pancreatic cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Oxaliplatin may also make the tumor cells more sensitive to radiation therapy. Giving radiation therapy with chemotherapy may kill more tumor cells.

Primary Outcome

1-year survival will be considered "success". The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. If more than 1 patients is lost to follow-up, we will use Kaplan-Meier estimates for the 6-month and 12-month overall survival rates. 95% confidence intervals for the true success proportion will be calculated according the approach of Duffy and Santner.

Interventions

  • DRUG oxaliplatin
  • DRUG fluorouracil
  • RADIATION radiation therapy
  • DRUG gemcitabine hydrochloride

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2004-12
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00096070 record still lists

NCT00096070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 4 interventions - of which oxaliplatin is the first listed.

NCT00096070 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00096070 about?

NCT00096070 is a clinical study titled "Radiotherapy Combined With Oxaliplatin and Fluorouracil Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer". This phase II trial is studying how well giving radiation therapy together with oxaliplatin and fluorouracil followed by gemcitabine works in treating patients with locally advanced, unresectable pancreatic cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemot...

What is the current status of trial NCT00096070?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2004-12.

What interventions are being tested in trial NCT00096070?

The interventions under investigation include: oxaliplatin (DRUG), fluorouracil (DRUG), radiation therapy (RADIATION), gemcitabine hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00096070?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00096070's enrollment target sits among peer trials

50 1195th of 2000 higher than 740 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 NCT00096070, the US trial registry maintained by the National Library of Medicine. NCT00096070 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.