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Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00542490
First Posted: October 11, 2007
Last Update Posted: September 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Oklahoma
Results First Submitted: April 14, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Endometrial Cancer
Papillary Serous
Clear Cell Endometrial Cancer
Intervention: Radiation: Vaginal Cuff Brachytherapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Vaginal Cuff Brachytherapy

Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged.

Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)


Participant Flow:   Overall Study
    Vaginal Cuff Brachytherapy
STARTED   23 
COMPLETED   21 
NOT COMPLETED   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Vaginal Cuff Brachytherapy

Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged.

Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)


Baseline Measures
   Vaginal Cuff Brachytherapy 
Overall Participants Analyzed 
[Units: Participants]
 23 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      6  26.1% 
>=65 years      17  73.9% 
Age 
[Units: Years]
Mean (Full Range)
 69 
 (46 to 81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      23 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   23 


  Outcome Measures
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1.  Primary:   Number of Patients With Progression-free Survival at 2 Years   [ Time Frame: 2 years ]

2.  Secondary:   Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lisa Landrum, MD
Organization: University of Oklahoma
phone: 405 271-8001
e-mail: lisa-landrum@ouhsc.edu



Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00542490     History of Changes
Other Study ID Numbers: 1524
First Submitted: October 10, 2007
First Posted: October 11, 2007
Results First Submitted: April 14, 2017
Results First Posted: September 27, 2017
Last Update Posted: September 27, 2017