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NCT00338988 · ClinicalTrials.gov registry record · Phase 2
Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT00338988: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00338988 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00338988, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
This is a Phase II trial of the combination of oxaliplatin (Eloxatin) and capecitabine (Xeloda), known as XELOX, in participants with unresectable or recurrent cholangiocarcinoma, including carcinoma of the gallbladder or biliary tract, both intrahepatic and extrahepatic. Participants may be either previously untreated or treated with chemotherapy. Participants will accrue to two strata based on pre-treatment status; separate response rates and statistical operating characteristics will be applied to each stratum. The primary objective is to determine the objective response rate (complete plus partial) of XELOX in this population. Secondary objectives include determining toxicity, stable disease rates, and median and overall survival of participants treated with this combination.
Primary Outcome
Objective Response = Complete Response + Partial Response. Response evaluated using modification of new international criteria proposed by RECIST \[changes in only largest diameter (unidimensional measurement) of tumor lesions used in the RECIST criteria\]. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Interventions
- DRUG Capecitabine
- DRUG Oxaliplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2003-08 |
| Est. Completion | 2009-05 |
| Phase | Phase 2 |
What the finished NCT00338988 record still lists
NCT00338988 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.
NCT00338988 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00338988 about?
NCT00338988 is a clinical study titled "Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma". This is a Phase II trial of the combination of oxaliplatin (Eloxatin) and capecitabine (Xeloda), known as XELOX, in participants with unresectable or recurrent cholangiocarcinoma, including carcinoma of the gallbladder or biliary tract, both intrahepatic and extrahepatic. Participants may be either ...
What is the current status of trial NCT00338988?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2003-08. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00338988?
The interventions under investigation include: Capecitabine (DRUG), Oxaliplatin (DRUG).
Who is sponsoring clinical trial NCT00338988?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00338988's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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