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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 is a Phase 2 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 69 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00590967
The ClinicalTrials.gov registry entry for NCT00590967 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT00590967 reports 0 study locations.
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.
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