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NCT00002525 · ClinicalTrials.gov registry record · Phase 3

Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed

A Phase 3 study, sponsored by ECOG-ACRIN Cancer Research Group.

Terminated
Registry status
Phase 3
Development phase
859
Enrollment target

NCT00002525: Clinical Trial Phase 3 study, sponsored by ECOG-ACRIN Cancer Research Group.

NCT00002525 is a Phase 3 study that was terminated before completion, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 859 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00002525, a Phase 3 study, was terminated before completion, sponsored by ECOG-ACRIN Cancer Research Group.

TERMINATED
Registry status
Phase 3
Development phase
859 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for colon cancer. PURPOSE: Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil (5-FU) chemotherapy after curative resection could improve overall survival and disease-free survival in patients with Duke's B3 or C colon cancer.

Primary Outcome

Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate

Interventions

  • DRUG fluorouracil
  • DRUG leucovorin calcium

Trial Details

FieldValue
Enrollment Target 859 participants
Start Date 1993-10-01
Est. Completion 2015-04
Phase Phase 3
ECOG-ACRIN Cancer Research Group

75 total trials

Why NCT00002525 stopped before completion

NCT00002525 is an interventional study that assigns participants to a tested intervention. The registered 859 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% higher).

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

NCT00002525 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00002525 about?

NCT00002525 is a clinical study titled "Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for colon c...

What is the current status of trial NCT00002525?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 859 participants. The study started on 1993-10-01. Estimated completion is 2015-04.

What interventions are being tested in trial NCT00002525?

The interventions under investigation include: fluorouracil (DRUG), leucovorin calcium (DRUG).

Who is sponsoring clinical trial NCT00002525?

This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00002525's enrollment target sits among peer trials

859 383rd of 2000 higher than 1,618 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00002525, the US trial registry maintained by the National Library of Medicine. NCT00002525 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.