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NCT00079274 · ClinicalTrials.gov registry record · Phase 3
Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 3,397
- Enrollment target
NCT00079274: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00079274 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 3,397 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00079274, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,397 participants
- Enrollment target
Study Summary
This randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3 but with cetuximab) in treating patients who have undergone surgery for stage III colon cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with monoclonal antibody therapy and giving them after surgery may kill any remaining tumor cells. It was not known at the time this study was developed which combination chemotherapy regimen is more effective after surgery in treating colon cancer. This study had several key changes, based on the results of other phase III trials. As of 6/1/2005, patients no longer received irinotecan on this study and treatment arms B, C, E, and F were discontinued. Patients on arms B and C crossed to arm A. Patients on arms E and F crossed to arm D. Patients on arms C and F who had not gotten to irinotecan continued on arms A and D, respectively. As of 8/18/2008, pre-screening for Kirsten rat sarcoma (KRAS) status was added with mutant KRAS (or KRAS not evaluable) patients put on arm G and wild-type KRAS patients randomized between arm A and arm D. Patients on arm G were treated per physician discretion and followed for disease and survival status. KRAS was determined in a central laboratory and was process for all patients on this study. The primary endpoint of this study was modified on 8/18/2008 to focus on patients having wild-type KRAS tumors. All modifications were approved by the Central Inst
Interventions
- DRUG oxaliplatin
- DRUG fluorouracil
- BIOLOGICAL cetuximab
- DRUG leucovorin calcium
- DRUG irinotecan hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,397 participants |
| Start Date | 2004-02 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00079274
The ClinicalTrials.gov registry entry for NCT00079274 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,397 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which oxaliplatin is the first listed.
NCT00079274 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00079274 about?
NCT00079274 is a clinical study titled "Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer". This randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3...
What is the current status of trial NCT00079274?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,397 participants. The study started on 2004-02. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00079274?
The interventions under investigation include: oxaliplatin (DRUG), fluorouracil (DRUG), cetuximab (BIOLOGICAL), leucovorin calcium (DRUG), irinotecan hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00079274?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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