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Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer

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ClinicalTrials.gov Identifier: NCT00542490
Recruitment Status : Completed
First Posted : October 11, 2007
Results First Posted : September 27, 2017
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

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
Enrollment 23

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vaginal Cuff Brachytherapy
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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)

Period Title: Overall Study
Started 23
Completed 21
Not Completed 2
Arm/Group Title Vaginal Cuff Brachytherapy
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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)

Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  26.1%
>=65 years
17
  73.9%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants
69
(46 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
23
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
 100.0%
1.Primary Outcome
Title Number of Patients With Progression-free Survival at 2 Years
Hide Description [Not Specified]
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
19 of the 23 patients completed VCB and 3 cycles of chemotherapy
Arm/Group Title Vaginal Cuff Brachytherapy
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
19
  82.6%
2.Secondary Outcome
Title Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy
Hide Description [Not Specified]
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vaginal Cuff Brachytherapy
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
23
 100.0%
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vaginal Cuff Brachytherapy
Hide Arm/Group Description

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)

All-Cause Mortality
Vaginal Cuff Brachytherapy
Affected / at Risk (%)
Total   0/23 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Vaginal Cuff Brachytherapy
Affected / at Risk (%) # Events
Total   1/23 (4.35%)    
Blood and lymphatic system disorders   
neutropenic fever   1/23 (4.35%)  1
Gastrointestinal disorders   
Gastrointestinal bleed  [1]  1/23 (4.35%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary Embolism   1/23 (4.35%)  1
Indicates events were collected by systematic assessment
[1]
gastrointestinal bleed following radiation therapy
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Vaginal Cuff Brachytherapy
Affected / at Risk (%) # Events
Total   1/23 (4.35%)    
General disorders   
Grade 4 Fatigue   1/23 (4.35%)  1
Indicates events were collected by systematic assessment
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
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