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NCT00590967 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy
A Phase 2 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
NCT00590967: Clinical Trial Phase 2 study, sponsored by Washington University School of Medicine.
NCT00590967 is a Phase 2 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 69 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00590967, a Phase 2 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
Study Summary
Recent studies have shown that the chance of survival among women with advanced cervical cancer is increased when they receive concurrent chemotherapy and radiation to the pelvis. However, patients who have advanced disease show loco-regional failure as well as a high incidence of distant metastasis. Positron emission tomography (PET) scanning has high sensitivity and specificity in the detection of pelvic and para-aortic lymph node metastases. While the detection of para-aortic metastases by PET significantly impacts prognosis, PET has been known to show positive lymph node metastasis in the pelvis only while not detecting micrometastatic disease in the para-aortic lymph nodes (despite the fact that they are histologically known). In addition, patients with positive para-aortic lymph nodes on PET, greater amounts (more than 45 Gy) of radiation must be used to improve the probability of controlling the cancer. However, doses greater than this have been limited because of the dose and volume limits to the small bowel. But, Intensity Modulated Radiation Therapy (IMRT) is a new way of calculating and delivering radiation therapy. Compared to external beam radiation, IMRT has the improved ability to deliver large doses of radiation to specific targets while minimizing the exposure to surrounding normal tissue. With IMRT, however, the effective dose/volume can be increased more safely and lower the toxicity of surrounding tissue, thus making prophylactic dosing to para-aortic lymph nodes not detected by PET safer and more effective.
Primary Outcome
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.
Interventions
- DRUG Cisplatin
- RADIATION Brachytherapy
- RADIATION IMRT extended field external beam radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2003-05 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
Why NCT00590967 stopped before completion
NCT00590967 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT00590967 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00590967 about?
NCT00590967 is a clinical study titled "A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy". Recent studies have shown that the chance of survival among women with advanced cervical cancer is increased when they receive concurrent chemotherapy and radiation to the pelvis. However, patients who have advanced disease show loco-regional failure as well as a high incidence of distant metastasis...
What is the current status of trial NCT00590967?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2003-05. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00590967?
The interventions under investigation include: Cisplatin (DRUG), Brachytherapy (RADIATION), IMRT extended field external beam radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT00590967?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00590967's enrollment target sits among peer trials
69 965th of 2000 higher than 1,034 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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