Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
Public ClinicalTrials.gov record NCT00005036. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients With Advanced Colorectal Carcinoma Previously Treated With 5-FU
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00005036
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 560 participants
Conditions and interventions
Conditions
- Mucinous Adenocarcinoma of the Colon
- Mucinous Adenocarcinoma of the Rectum
- Recurrent Colon Cancer
- Recurrent Rectal Cancer
- Signet Ring Adenocarcinoma of the Colon
- Signet Ring Adenocarcinoma of the Rectum
- Stage IIIA Colon Cancer
- Stage IIIA Rectal Cancer
- Stage IIIB Colon Cancer
- Stage IIIB Rectal Cancer
- Stage IIIC Colon Cancer
- Stage IIIC Rectal Cancer
- Stage IVA Colon Cancer
- Stage IVA Rectal Cancer
- Stage IVB Colon Cancer
- Stage IVB Rectal Cancer
Interventions
- irinotecan hydrochloride Drug
- oxaliplatin Drug
- leucovorin calcium Drug
- fluorouracil Drug
- quality-of-life assessment Procedure
Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 1999
- Primary completion
- Nov 30, 2006
- Completion
- Not listed
- Last update posted
- May 2, 2013
Started 1999
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| North Central Cancer Treatment Group | Rochester | Minnesota | 55905 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00005036, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 2, 2013 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00005036 live on ClinicalTrials.gov.