Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer

• Status: Active, not recruiting
• Trial end date: 2022-12-13
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

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.