We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
October 10, 2007
October 11, 2007
April 14, 2017
September 27, 2017
September 27, 2017
September 2007
February 2016   (Final data collection date for primary outcome measure)
Number of Patients With Progression-free Survival at 2 Years [ Time Frame: 2 years ]
To determine the progression-free survival of patients with surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with high-intermediate risk factors treated by vaginal cuff brachytherapy followed by chemotherapy. [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00542490 on ClinicalTrials.gov Archive Site
Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy [ Time Frame: 2 years ]
To determine the toxicity of vaginal cuff brachytherapy followed by carboplatin and paclitaxel chemotherapy. [ Time Frame: 2 years ]
Not Provided
Not Provided
 
Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer
Phase II Trial of Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy in Patients With Stage I-IIb Papillary Serous, Clear Cell and Endometrioid Endometrial Cancer With High-Intermediate Risk Factors
The purpose of this study is to determine the progression-free survival of patients with surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with high-intermediate risk factors treated by vaginal cuff brachytherapy followed by chemotherapy.
All patients must have undergone complete surgical staging including bilateral pelvic and para-aortic lymphadenectomy. All patients will receive radiation therapy. Treatment will be delivered either by LDR or HDR brachytherapy. The treatment plan must be started at the time of enrollment. The vaginal brachytherapy should be started within 4 weeks of surgery (within 2 weeks of enrollment), in order to avoid delays in initiation of systemic therapy, which should start on post-operative day 21. The dose will be prescribed to the vaginal (mucosal) surface as defined at the surface of the applicators. Following vaginal cuff radiation therapy, all patients will receive chemotherapy.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Endometrial Cancer
  • Papillary Serous
  • Clear Cell Endometrial Cancer
Radiation: 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)
Experimental: Vaginal Cuff Brachytherapy
Intervention: Radiation: Vaginal Cuff Brachytherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
February 2016
February 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients must have undergone specified complete surgical staging.
  • Patients must be surgically staged endometrial cancer patients at high-risk for recurrence.
  • Patients must have adequate bone marrow, renal and hepatic function.

Exclusion Criteria:

  • Patients with recurrent disease.
  • Patients with GOG performance status of 3 or 4.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00542490
1524
No
Not Provided
Not Provided
University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Scott McMeekin, MD University of Oklahoma
University of Oklahoma
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP