Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00005036 · ClinicalTrials.gov registry record · Phase 3
Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 560
- Enrollment target
NCT00005036: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00005036 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 560 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005036, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 560 participants
- Enrollment target
Study Summary
Randomized phase III trial to compare the effectiveness of irinotecan with that of combination chemotherapy in treating patients who have advanced colorectal cancer that has not responded to previous treatment. 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 colorectal cancer.
Primary Outcome
The primary analysis for this trial will be based on a one-sided Generalized Wilcoxon test.
Interventions
- DRUG oxaliplatin
- PROCEDURE quality-of-life assessment
- DRUG fluorouracil
- DRUG leucovorin calcium
- DRUG irinotecan hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 560 participants |
| Start Date | 1999-11 |
| Phase | Phase 3 |
What the finished NCT00005036 record still lists
NCT00005036 is an interventional study that assigns participants to a tested intervention. The registered 560 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 5 interventions - of which oxaliplatin is the first listed.
NCT00005036 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00005036 about?
NCT00005036 is a clinical study titled "Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer". Randomized phase III trial to compare the effectiveness of irinotecan with that of combination chemotherapy in treating patients who have advanced colorectal cancer that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they s...
What is the current status of trial NCT00005036?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 560 participants. The study started on 1999-11.
What interventions are being tested in trial NCT00005036?
The interventions under investigation include: oxaliplatin (DRUG), quality-of-life assessment (PROCEDURE), fluorouracil (DRUG), leucovorin calcium (DRUG), irinotecan hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00005036?
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 NCT00005036's enrollment target sits among peer trials
560 671st of 2000 higher than 1,328 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04661358 · 560 participants · Phase 3
Fenofibrate for Prevention of DR Worsening
- NCT05473871 · 560 participants · NA
Enhancing Capacity in Churches to Implement PA Programs
- NCT06001541 · 560 participants · NA
Web-based Program to Improve Self-management Among Veterans-caregiver Dyads
- NCT06246916 · 560 participants · Phase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia