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NCT00004931 · ClinicalTrials.gov registry record · Phase 3

Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer

A Phase 3 study of Stage III Colon Cancer and Stage II Colon Cancer, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 3
Development phase
2,472
Enrollment target
1
Study location

NCT00004931: Completed Phase 3 study of Stage III Colon Cancer and Stage II Colon Cancer, sponsored by National Cancer Institute (NCI).

NCT00004931 is a Phase 3 study of Stage III Colon Cancer and Stage II Colon Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 2,472 participants, above the 404-participant average among 6 other Stage III Colon Cancer trials with a reported enrollment target (512% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00004931, a Phase 3 study of Stage III Colon Cancer and Stage II Colon Cancer, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 3
Development phase
2,472 participants
Enrollment target
1
Study location

Study Summary

Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without oxaliplatin in treating patients who have stage II or stage III colon cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for colon cancer

Conditions Studied

Stage III Colon Cancer Stage II Colon Cancer

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG oxaliplatin
  • DRUG fluorouracil
  • DRUG leucovorin calcium

Study Locations (1)

Pennsylvania

  • National Surgical Adjuvant Breast and Bowel Project - Pittsburgh

Trial Details

FieldValue
Enrollment Target 2,472 participants
Start Date 2000-02
Phase Phase 3
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00004931 record still lists

NCT00004931 is an interventional study that assigns participants to a tested intervention. Its 2,472 participants enrollment target places it among the larger protocols in the corpus, above the 404-participant average among 6 other Stage III Colon Cancer trials with a reported enrollment target (512% higher).

The record links to 2 conditions, with Stage III Colon Cancer appearing as the primary indexed condition, and to 4 interventions - of which laboratory biomarker analysis is the first listed.

NCT00004931 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00004931 about?

NCT00004931 is a clinical study titled "Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer". Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without oxaliplatin in treating patients who have stage II or stage III colon cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining...

What is the current status of trial NCT00004931?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,472 participants. The study started on 2000-02.

What conditions does trial NCT00004931 study?

This clinical trial studies the following conditions: Stage III Colon Cancer, Stage II Colon Cancer.

What interventions are being tested in trial NCT00004931?

The interventions under investigation include: laboratory biomarker analysis (OTHER), oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin calcium (DRUG).

Who is sponsoring clinical trial NCT00004931?

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

Where is trial NCT00004931 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT00004931, the US trial registry maintained by the National Library of Medicine. NCT00004931 (large enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.