Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer
Condition: Endometrial Cancer; Papillary Serous; Clear Cell Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Intervention: Vaginal Cuff Brachytherapy; Carboplatin; Paclitaxel
Intervention description: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted; Carboplatin IV on day 1 of a 21 day cycle for 3 cycles; Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: Female
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Endometrial Cancer; Gynecologic Cancer; radiation therapy

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.
    

Eligibility 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.