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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. 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.
Interventions
- DRUG Capecitabine
- DRUG Oxaliplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2003-08 |
| Est. Completion | 2009-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00338988
The ClinicalTrials.gov registry entry for NCT00338988 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.
NCT00338988 reports 0 study locations.
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.
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