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NCT00069108 · ClinicalTrials.gov registry record · Phase 3
A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer
A Phase 3 study of Colorectal Cancer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 627
- Enrollment target
- 20
- Study locations
NCT00069108: Completed Phase 3 study of Colorectal Cancer, sponsored by Hoffmann-La Roche.
NCT00069108 is a Phase 3 study of Colorectal Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 627 participants, below the 1,543-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00069108, a Phase 3 study of Colorectal Cancer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 627 participants
- Enrollment target
- 20
- Study locations
Study Summary
This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
Primary Outcome
Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0, wherein progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions (TLs), taking as reference the smallest sum LD recorded since the treatment started or
Conditions Studied
Interventions
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG capecitabine [Xeloda]
- DRUG 5 FU
Study Locations (20)
Other
- - Brussels
- - Brussels
- - Ghent
- - Kortrijk
- - Mont-godinne
Ontario
- - London
- - Oshawa
- - Ottawa
- - Saint Catherines
California
- - Bakersfield
Colorado
- - Colorado Springs
District of Columbia
- - Washington D.C.
Indiana
- - Terre Haute
Missouri
- - St Louis
Montana
- - Billings
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 627 participants |
| Start Date | 2003-07 |
| Est. Completion | 2006-08 |
| Phase | Phase 3 |
What the finished NCT00069108 record still lists
NCT00069108 is an interventional study that assigns participants to a tested intervention. The registered 627 participants enrollment target is mid-sized for trials with a published cap, below the 1,543-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 4 interventions - of which Leucovorin is the first listed.
NCT00069108 names 20 study sites across 13 states, led by Other, Ontario, California.
Frequently Asked Questions
What is clinical trial NCT00069108 about?
NCT00069108 is a clinical study titled "A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer". This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000m...
What is the current status of trial NCT00069108?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 627 participants. The study started on 2003-07. Estimated completion is 2006-08.
What conditions does trial NCT00069108 study?
This clinical trial studies the following conditions: Colorectal Cancer.
What interventions are being tested in trial NCT00069108?
The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), capecitabine [Xeloda] (DRUG), 5 FU (DRUG).
Who is sponsoring clinical trial NCT00069108?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00069108 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Indiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00069108's enrollment target sits among peer trials
627 70th of 381 higher than 312 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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.
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