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Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer
NCT01652794 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this phase I study is to determine the highest dose of carboplatin and gemcitabine (gemcitabine hydrochloride) that can be given safely to subjects with gynecologic cancer, in combination with stereotactic body radiation therapy (SBRT). This dose is called the maximum tolerated dose (MTD). To determine the MTD, patients will receive different amounts of carboplatin and gemcitabine.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG carboplatin
- RADIATION stereotactic body radiation therapy
- OTHER pharmacogenomic studies
- DRUG gemcitabine hydrochloride
Study Locations (1)
Ohio
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01652794
The ClinicalTrials.gov registry entry for NCT01652794 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Comprehensive Cancer Center, which has 276 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Recurrent Endometrial Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which laboratory biomarker analysis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01652794 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01652794 about?
NCT01652794 is a clinical study titled "Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer". The purpose of this phase I study is to determine the highest dose of carboplatin and gemcitabine (gemcitabine hydrochloride) that can be given safely to subjects with gynecologic cancer, in combination with stereotactic body radiation therapy (SBRT). This dose is called the maximum tolerated dose (...
What is the current status of trial NCT01652794?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2012-05. Estimated completion is 2015-03.
What conditions does trial NCT01652794 study?
This clinical trial studies the following conditions: Recurrent Endometrial Carcinoma, Recurrent Ovarian Epithelial Cancer, Recurrent Fallopian Tube Cancer, Ovarian Sarcoma, Recurrent Cervical Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01652794?
The interventions under investigation include: laboratory biomarker analysis (OTHER), carboplatin (DRUG), stereotactic body radiation therapy (RADIATION), pharmacogenomic studies (OTHER), gemcitabine hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01652794?
This trial is sponsored by Case Comprehensive Cancer Center, which has 276 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01652794 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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