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Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer

Primary Purpose

Endometrial Cancer, Papillary Serous, Clear Cell Endometrial Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vaginal Cuff Brachytherapy
Carboplatin
Paclitaxel
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring Endometrial Cancer, Gynecologic Cancer, radiation therapy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. All patients must have undergone hysterectomy. Bilateral salpingooophorectomy is strongly encouraged but not mandatory.
  2. Pelvic and para-aortic lymphadenectomy are optional, but strongly encouraged. Peritoneal washing are optional.
  3. If either a bilateral salpingo-oophorectomy or nodal dissection was not performed, post-operative pre-treatment CT/MRI is required and must not demonstrate evidence suggestive of metastatic disease (adnexa, nodes, intraperitoneal disease). Post-operative, pre-treatment CT/MRI must be performed if a pelvic and para-aortic nodal dissection was not performed.

  4. All patients will be staged according to the FIGO 2009 staging system and with endometrial carcinoma (endometrioid types) confined to the corpus uteri or with endocervical glandular involvement fitting one of the following high-intermediate risk factor categories:

    • age ≥18 years with 3 risk factors

    • Risk factors:

      1. Grade 2 or 3 tumor, (+) lymphovascular space invasion, outer ½ myometrial invasion. Patients with these risk criteria may be enrolled with either positive or negative cytology.
      2. Patients with Stage II endometrial carcinoma (any histology) with cervical stromal invasion. (occult or gross involvement), with or without high-intermediate risk factors.
      3. Patients with serous or clear cell histology (with or without other high-intermediate risk factors) are eligible provided the disease is uterine-confined (with or without cervical stromal invasion or endocervical glandular involvement).
  5. Patients must have GOG performance status 0, 1, or 2.
  6. Patients must have adequate bone marrow, renal, hepatic and neurologic function per protocol.
  7. Patients who have met the pre-entry requirements specified in protocol; testing values/results must meet eligibility criteria specified in protocol.
  8. Patients must have signed an approved informed consent and authorization permitting release of personal health information.

Exclusion Criteria:

  1. Patients with recurrent disease.
  2. Patients with GOG performance status of 3 or 4.
  3. Greater than 12 weeks elapsed from surgery to enrollment.
  4. Patients have prior pelvic or abdominal radiation therapy.
  5. Known hypersensitivity to any component of study treatment that resulted in drug discontinuation.
  6. Significant intercurrent illness including, but not limited to, unstable angina pectoris, and cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
  7. Active pregnancy or lactation.
  8. Prior malignancy requiring treatment within the last 3 years.

Sites / Locations

  • Stephenson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaginal Cuff Brachytherapy + Chemotherapy

Arm Description

Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles

Outcomes

Primary Outcome Measures

Number of Patients Completing the Protocol
Defined as completion of vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy

Secondary Outcome Measures

Frequency of Adverse Events Related to Acute Toxicity During Treatment
Frequency and severity of adverse events as assessed by the CTCAE v4
Sites of Failure
Proportion of participants who recur in regional versus distant recurrence
Recurrence-free Survival
time from study entry to the first tumor recurrence
Contributing Cause of Death
The contributing cause of death for patients with high risk endometrial cancer
Overall Survival
time from study entry to death

Full Information

First Posted
May 24, 2017
Last Updated
August 13, 2021
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT03189446
Brief Title
Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer
Official Title
Phase II Trial of Vaginal Cuff Brachytherapy Followed by Adjuvant Chemotherapy With Carboplatin and Dose Dense Paclitaxel in Patients With High-Risk Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
December 13, 2019 (Actual)
Study Completion Date
December 13, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the feasibility of treatment in patients with high risk endometrial cancer treated by vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy.
Detailed Description
Before the patient begins the study: Endometrial cancer is commonly treated with surgery. The patient must have already had surgery including hysterectomy (removal of the uterus) prior to being considered eligible for this study. The surgery may also include removal of pelvic and para-aortic lymph nodes. Following the surgery, the doctor will identify if the patient has factors related to the cancer which places the patient at a greater risk for the cancer returning. Prior to participating in this study there are exams, tests or procedures to find out if the patient can be treated in the study. Most are part of regular cancer care. Treatment: All patients will receive radiation therapy followed by three cycles of dose dense paclitaxel and carboplatin chemotherapy. Radiation therapy will be delivered either by LDR or HDR brachytherapy and must be specified at the time of enrollment. The vaginal brachytherapy should be started within 12 weeks of surgery (within 2 weeks of enrollment). Chemotherapy should start within 3 weeks of initiating brachytherapy. Study participation will be up to two years.

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, radiation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaginal Cuff Brachytherapy + Chemotherapy
Arm Type
Experimental
Arm Description
Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles
Intervention Type
Radiation
Intervention Name(s)
Vaginal Cuff Brachytherapy
Intervention Description
Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin IV on day 1 of a 21 day cycle for 3 cycles
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
Primary Outcome Measure Information:
Title
Number of Patients Completing the Protocol
Description
Defined as completion of vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Frequency of Adverse Events Related to Acute Toxicity During Treatment
Description
Frequency and severity of adverse events as assessed by the CTCAE v4
Time Frame
4 months
Title
Sites of Failure
Description
Proportion of participants who recur in regional versus distant recurrence
Time Frame
up to 2 years
Title
Recurrence-free Survival
Description
time from study entry to the first tumor recurrence
Time Frame
up to 2 years
Title
Contributing Cause of Death
Description
The contributing cause of death for patients with high risk endometrial cancer
Time Frame
up to 2 years
Title
Overall Survival
Description
time from study entry to death
Time Frame
up to 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients must have undergone hysterectomy. Bilateral salpingooophorectomy is strongly encouraged but not mandatory. Pelvic and para-aortic lymphadenectomy are optional, but strongly encouraged. Peritoneal washing are optional. If either a bilateral salpingo-oophorectomy or nodal dissection was not performed, post-operative pre-treatment CT/MRI is required and must not demonstrate evidence suggestive of metastatic disease (adnexa, nodes, intraperitoneal disease). Post-operative, pre-treatment CT/MRI must be performed if a pelvic and para-aortic nodal dissection was not performed. All patients will be staged according to the FIGO 2009 staging system and with endometrial carcinoma (endometrioid types) confined to the corpus uteri or with endocervical glandular involvement fitting one of the following high-intermediate risk factor categories: age ≥18 years with 3 risk factors Risk factors: Grade 2 or 3 tumor, (+) lymphovascular space invasion, outer ½ myometrial invasion. Patients with these risk criteria may be enrolled with either positive or negative cytology. Patients with Stage II endometrial carcinoma (any histology) with cervical stromal invasion. (occult or gross involvement), with or without high-intermediate risk factors. Patients with serous or clear cell histology (with or without other high-intermediate risk factors) are eligible provided the disease is uterine-confined (with or without cervical stromal invasion or endocervical glandular involvement). Patients must have GOG performance status 0, 1, or 2. Patients must have adequate bone marrow, renal, hepatic and neurologic function per protocol. Patients who have met the pre-entry requirements specified in protocol; testing values/results must meet eligibility criteria specified in protocol. Patients must have signed an approved informed consent and authorization permitting release of personal health information. Exclusion Criteria: Patients with recurrent disease. Patients with GOG performance status of 3 or 4. Greater than 12 weeks elapsed from surgery to enrollment. Patients have prior pelvic or abdominal radiation therapy. Known hypersensitivity to any component of study treatment that resulted in drug discontinuation. Significant intercurrent illness including, but not limited to, unstable angina pectoris, and cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements Active pregnancy or lactation. Prior malignancy requiring treatment within the last 3 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Moore, MD
Organizational Affiliation
Stephenson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer

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