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NCT00256308 · ClinicalTrials.gov registry record · Phase 2
Adjuvant Chemoradiation With Weekly Oxaliplatin in Resected Head and Neck Cancer
A Phase 2 study, sponsored by University of California, Irvine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT00256308: Clinical Trial Phase 2 study, sponsored by University of California, Irvine.
NCT00256308 is a Phase 2 study that was terminated before completion, run by University of California, Irvine. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00256308, a Phase 2 study, was terminated before completion, sponsored by University of California, Irvine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
Oxaliplatin-containing regimens have been safely and successfully used in combination with concurrent radiation in treatment of solid tumors such as rectal and esophageal cancers. The Lyon R0-04 phase II trial utilized the combination of Oxaliplatin, infusional 5-fluorouracil (5-FU) and radiation in the treatment of rectal cancer. The trial showed a combined preoperative chemoradiotherapy and Oxaliplatin-containing regimen is well tolerated with no increase surgical toxicity. The good response rate observed warrants its use in further clinical trials. The combination of oxaliplatin, 5-FU, and radiation also have been used in a Phase I/II trial in esophageal cancer. In this particular trial, eligibility included therapeutically naïve esophageal cancer subjects with clinical disease stages II to IV. Initial doses and schedules for cycle 1 consisted of Oxaliplatin 85 mg/m2 on days 1, 15, and 29; continuous infusion of 5-FU 180 mg/m2 for 24 hours for 35 days; and radiation therapy (RT) 1.8 Gy in 28 fractions starting on day 8. At completion of cycle 1, eligible subjects could undergo an operation or begin cycle 2 without RT. Postoperative subjects were eligible for cycle 2. Stage IV subjects were allowed three cycles in the absence of disease progression. 38 subjects were treated (22 stage IV, 16 stage II-III). 38 eligible subjects received therapy: 22 non-invasively staged as IV and 16 non-invasively staged as IV and 16 non-invasively staged as II and III. 36 subjects completed cycle 1, 29 subjects started cycle 2, and 24 subjects completed cycle 2. The combined-modality therapy was well tolerated, but dose limiting toxicity (DLT) prevented Oxaliplatin and 5-FU escalation. No grade 4 hematologic toxicity was noted. Eleven grade 3 and two grade 4 clinical toxicities were noted in eight subjects. After cycle 1, 29 subjects (81%) had no cancer in the esophageal mucosa. 13 subjects underwent an operation with intent to resect the esophagus and 5 subjects (38%) exhibited p
Primary Outcome
Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.
Interventions
- DRUG Oxaliplatin
- PROCEDURE Radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2005-02 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
Why NCT00256308 stopped before completion
NCT00256308 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Oxaliplatin is the first listed.
NCT00256308 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00256308 about?
NCT00256308 is a clinical study titled "Adjuvant Chemoradiation With Weekly Oxaliplatin in Resected Head and Neck Cancer". Oxaliplatin-containing regimens have been safely and successfully used in combination with concurrent radiation in treatment of solid tumors such as rectal and esophageal cancers. The Lyon R0-04 phase II trial utilized the combination of Oxaliplatin, infusional 5-fluorouracil (5-FU) and radiation in...
What is the current status of trial NCT00256308?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2005-02. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00256308?
The interventions under investigation include: Oxaliplatin (DRUG), Radiation (PROCEDURE).
Who is sponsoring clinical trial NCT00256308?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00256308's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 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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