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: September 6, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Surgically Staged Endometrial Cancer
Stage IIb Endometrial Cancer
Stage I-IIb Papillary Serous
Stage I-IIb Clear Cell Endometrial Cancer
Radiation: Vaginal Cuff Brachytherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To determine the toxicity of vaginal cuff brachytherapy followed by carboplatin and paclitaxel chemotherapy. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: September 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542490

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

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00542490     History of Changes
Other Study ID Numbers: Vaginal Cuff Brachy
Study First Received: October 10, 2007
Last Updated: September 6, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors

ClinicalTrials.gov processed this record on April 16, 2014