Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer

Endometrial Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542490
• Other study ID #: 1524
• Status: Completed
• Phase: Phase 2
• Start date: September 2007
• Est. completion date: February 2016

Study information

• Verified date: August 2020
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clear Cell Endometrial Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Papillary Serous

Intervention

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)

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Progression-free Survival at 2 Years		2 years
Secondary	Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy		2 years