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Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00542490
First received: October 10, 2007
Last updated: May 20, 2014
Last verified: May 2014

October 10, 2007
May 20, 2014
September 2007
December 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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
To determine the toxicity of vaginal cuff brachytherapy followed by carboplatin and paclitaxel chemotherapy. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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.
 
Active, not recruiting
120
December 2015
December 2015   (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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00542490
Vaginal Cuff Brachy
No
University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Scott McMeekin, MD University of Oklahoma
University of Oklahoma
May 2014

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