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Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer

Primary Purpose

Endometrial Cancer, Papillary Serous, Clear Cell Endometrial Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Vaginal Cuff Brachytherapy

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring Endometrial cancer, Gynecologic Cancer, Vaginal Cuff Brachytherapy, Vaginal radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaginal Cuff Brachytherapy

Arm Description

Outcomes

Primary Outcome Measures

Number of Patients With Progression-free Survival at 2 Years

Secondary Outcome Measures

Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy

Full Information

NCT ID

NCT00542490

First Posted

October 10, 2007

Last Updated

August 7, 2020

Sponsor

University of Oklahoma

1. Study Identification

Unique Protocol Identification Number

NCT00542490

Brief Title

Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer

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 Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oklahoma

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrial Cancer, Papillary Serous, Clear Cell Endometrial Cancer

Keywords

Endometrial cancer, Gynecologic Cancer, Vaginal Cuff Brachytherapy, Vaginal radiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vaginal Cuff Brachytherapy

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

Vaginal Cuff Brachytherapy

Intervention Description

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 Measure Information:

Title

Number of Patients With Progression-free Survival at 2 Years

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott McMeekin, MD

Organizational Affiliation

University of Oklahoma

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Oklahoma Health Sciences Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

12. IPD Sharing Statement

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Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer

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