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NCT00003835 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy in Treating Patients With Stage III Colon Cancer
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,260
- Enrollment target
NCT00003835: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00003835 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 1,260 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003835, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,260 participants
- Enrollment target
Study Summary
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 chemotherapy regimen is more effective for stage III colon cancer. Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without irinotecan in treating patients who have undergone surgery for stage III colon cancer.
Primary Outcome
The Cox proportional hazards model will be used to determine the association between each marker and time to recurrence and survival controlling for other baseline factors such as age, gender, treatment, primary tumor site, degree of differentiation.
Interventions
- OTHER laboratory biomarker analysis
- DRUG fluorouracil
- DRUG leucovorin calcium
- DRUG irinotecan hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,260 participants |
| Start Date | 1999-05 |
| Phase | Phase 3 |
What the finished NCT00003835 record still lists
NCT00003835 is an interventional study that assigns participants to a tested intervention. Its 1,260 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT00003835 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00003835 about?
NCT00003835 is a clinical study titled "Combination Chemotherapy in Treating Patients With 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 chemotherapy regimen is more effective for stage III colon cancer. Randomized phase III trial to compare the ...
What is the current status of trial NCT00003835?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,260 participants. The study started on 1999-05.
What interventions are being tested in trial NCT00003835?
The interventions under investigation include: laboratory biomarker analysis (OTHER), fluorouracil (DRUG), leucovorin calcium (DRUG), irinotecan hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00003835?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00003835's enrollment target sits among peer trials
1,260 204th of 2000 higher than 1,796 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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