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NCT01554410 · ClinicalTrials.gov registry record · Phase 1
Intensity Modulated Radiation Therapy With Cisplatin and Gemcitabine to Treat Locally Advanced Cervical Carcinoma
A Phase 1 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT01554410: Completed Phase 1 study, sponsored by University of California, San Diego.
NCT01554410 is a Phase 1 study that has completed, run by University of California, San Diego. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01554410, a Phase 1 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
The primary objective of the study is to identify the highest dose of gemcitabine that can be given safely with cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women with locally advanced cervical cancer. The investigators hypothesis is that IMRT will reduce gastrointestinal and hematologic toxicity, permitting escalating doses of gemcitabine to be feasibly delivered in patients with locally advanced cervical cancer.
Primary Outcome
To determine the maximum tolerated dose (MTD) of weekly gemcitabine that can be administered with concurrent weekly cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women with locally advanced cervical cancer
Interventions
- DRUG Cisplatin
- RADIATION Intensity Modulated Radiation Therapy (IMRT)
- DRUG Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2010-08 |
| Est. Completion | 2020-08-01 |
| Phase | Phase 1 |
What the finished NCT01554410 record still lists
NCT01554410 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT01554410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01554410 about?
NCT01554410 is a clinical study titled "Intensity Modulated Radiation Therapy With Cisplatin and Gemcitabine to Treat Locally Advanced Cervical Carcinoma". The primary objective of the study is to identify the highest dose of gemcitabine that can be given safely with cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women with locally advanced cervical cancer. The investigators hypothesis is that IMRT will reduce gastrointestinal and...
What is the current status of trial NCT01554410?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2010-08. Estimated completion is 2020-08-01.
What interventions are being tested in trial NCT01554410?
The interventions under investigation include: Cisplatin (DRUG), Intensity Modulated Radiation Therapy (IMRT) (RADIATION), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT01554410?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01554410's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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