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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Surgically Staged Endometrial Cancer, Stage IIb Endometrial Cancer, Stage I-IIb Papillary Serous, Stage I-IIb Clear Cell Endometrial Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Scott McMeekin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Oklahoma

Authority:

United States: Institutional Review Board

Study ID:

Vaginal Cuff Brachy

NCT ID:

NCT00542490

Start Date:

September 2007

Completion Date:

December 2012

Related Keywords:

  • Surgically Staged Endometrial Cancer
  • Stage IIb Endometrial Cancer
  • Stage I-IIb Papillary Serous
  • Stage I-IIb Clear Cell Endometrial Cancer
  • Endometrial cancer
  • Gynecologic Cancer
  • Vaginal Cuff Brachytherapy
  • Vaginal radiation
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104