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NCT01652794 · ClinicalTrials.gov registry record · Phase 1

Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer

A Phase 1 study of Recurrent Endometrial Carcinoma and Recurrent Ovarian Epithelial Cancer, sponsored by Case Comprehensive Cancer Center.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target
1
Study location

NCT01652794 is a Phase 1 study of Recurrent Endometrial Carcinoma and Recurrent Ovarian Epithelial Cancer that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 12 participants, below the 252-participant average among 19 other Recurrent Endometrial Carcinoma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01652794, a Phase 1 study of Recurrent Endometrial Carcinoma and Recurrent Ovarian Epithelial Cancer, has completed, sponsored by Case Comprehensive Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target
1
Study location

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.

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

FieldValue
Enrollment Target 12 participants
Start Date 2012-05
Est. Completion 2015-03
Phase Phase 1

Sponsor

Case Comprehensive Cancer Center

407 total trials

What the Registry Record Tells You About NCT01652794

The ClinicalTrials.gov registry entry for NCT01652794 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 252-participant average among 19 other Recurrent Endometrial Carcinoma trials with a reported enrollment target (95% lower). The listed sponsor is Case Comprehensive Cancer Center, which has 407 total studies on file at ClinicalTrials.gov.

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.

NCT01652794 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

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.

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).

Who is sponsoring clinical trial NCT01652794?

This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.