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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
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Papillary Serous Clear Cell Endometrial Cancer Radiation: Vaginal Cuff Brachytherapy Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2007
Primary Completion Date : February 2016
Study Completion Date : February 2016

Arm Intervention/treatment
Experimental: Vaginal Cuff Brachytherapy 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)

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542490

United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Principal Investigator: Scott McMeekin, MD University of Oklahoma

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00542490     History of Changes
Other Study ID Numbers: 1524
First Posted: October 11, 2007    Key Record Dates
Results First Posted: September 27, 2017
Last Update Posted: September 27, 2017
Last Verified: September 2017

Keywords provided by University of Oklahoma:
Endometrial cancer
Gynecologic Cancer
Vaginal Cuff Brachytherapy
Vaginal radiation

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female