Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer
Condition: Endometrial Clear Cell Adenocarcinoma; Endometrial Serous Adenocarcinoma; Fatigue; Neurotoxicity Syndrome; Obesity; Stage I Uterine Corpus Cancer AJCC v7; Stage II Uterine Corpus Cancer AJCC v7
MeSH terms: Adenocarcinoma; Cystadenocarcinoma, Serous; Adenocarcinoma, Clear Cell; Neurotoxicity Syndromes
Intervention: 3-Dimensional Conformal Radiation Therapy; Carboplatin; Intensity-Modulated Radiation Therapy; Internal Radiation Therapy; Laboratory Biomarker Analysis; Paclitaxel; Quality-of-Life Assessment; Questionnaire Administration
Intervention description: Undergo pelvic radiation therapy; Given IV; Undergo pelvic radiation therapy; Undergo vaginal cuff brachytherapy; Correlative studies; Given IV; Ancillary studies; Ancillary studies
Intervention MeSH terms: Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 601.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies pelvic radiation therapy to see how well it works
      compared with vaginal implant radiation therapy, paclitaxel, and carboplatin in treating
      patients with high-risk stage I or stage II endometrial cancer. Radiation therapy uses
      high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material
      placed directly into or near a tumor to kill tumor cells. Drugs used in chemotherapy, such as
      paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either
      by killing the cells, by stopping them from dividing, or by stopping them from spreading. It
      is not yet known whether pelvic radiation therapy alone is more effective than vaginal
      implant radiation therapy, paclitaxel, and carboplatin in treating patients with endometrial
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  To be considered eligible to participate in this trial, all patients must have
             undergone hysterectomy; bilateral salpingo-oophorectomy (open or laparoscopic
             approach) is strongly encouraged

          -  Peritoneal cytology should be obtained on entering the peritoneal cavity, as described
             in the Gynecologic Oncology Group (GOG) Surgical Procedures Manual
             (https://gogmember.gog.org/manuals/pdf/surgman.pdf); pelvic and para-aortic
             lymphadenectomy are optional, but strongly encouraged (as staged patients enrolled on
             GOG-0210-molecular markers in endometrial carcinoma are eligible for this study)

               -  The procedures may be performed via laparotomy or laparoscopy (including
                  robot-assisted) as per the surgeon?s preference; the surgeon must record in the
                  operative report whether a lymphadenectomy was performed (see link above to
                  Surgical Procedures Manual) or not; a specific number of lymph nodes removed will
                  not be utilized for eligibility, but the operative report should reflect that the
                  procedure performed was consistent with the procedures described in the GOG
                  Surgical Manual

          -  If either a bilateral salpingo-oophorectomy or nodal dissection was not performed,
             post-operative pre-treatment computed tomography (CT)/magnetic resonance imaging (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

          -  For the purposes of description, patients will be staged according to the
             International Federation of Gynecology and Obstetrics (FIGO) 2009 staging system;
             eligibility is defined based on clinical-pathologic features; patients 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 >= 70 years with one risk factor

               -  Age >= 50 with 2 risk factors

               -  Age >= 18 years with 3 risk factors

               -  Risk factors: grade 2 or 3 tumor, (+) lymphovascular space invasion, outer ?
                  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), and with peritoneal
             cytology negative for malignancy

          -  Patients must have GOG performance status 0, 1, or 2

          -  Absolute neutrophil count (ANC) >= 1,500/mcl (equivalent to Common Toxicity Criteria
             [CTCAE version [v] 3.0] grade 1)

          -  Platelets >= 100,000/mcl (CTCAE v3.0 grade 0-1)

          -  Serum creatinine =< institutional upper limit normal (ULN), CTCAE v 3.0 grade 0

               -  Note: If serum creatinine > ULN, a 24-hour creatinine clearance must be collected
                  and must be > 50 mL/min

          -  Bilirubin =< 1.5 x ULN (CTCAE v3.0 grade 1)

          -  Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x ULN (CTCAE grade 0-1)

          -  Alkaline phosphatase =< 2.5 x ULN (CTCAE grade 0-1)

          -  Neuropathy (sensory and motor) =< CTCAE v3.0 grade 1

          -  Patients who have met the pre-entry requirements; testing values/results must meet
             eligibility criteria

          -  Patients must have signed an approved informed consent and authorization permitting
             release of personal health information

        Exclusion Criteria:

          -  Patients who have already received non-surgical therapy for endometrial cancer
             including chemotherapy, radiation (example, pre-operative or post-operative
             brachytherapy), hormonal or biologic therapy

          -  Patients identified with pathologically confirmed spread of cancer beyond the uterus
             and cervix to pelvic or para-aortic lymph nodes, adnexal structures, and/or other
             anatomic sites, or patients with serous or clear cell histology and with positive
             cytologic washings

          -  Patients with nodal (for patients who did not have nodal dissection performed) or
             distant disease determined based on imaging studies; patients with suspicious nodes
             that have been biopsied (re-staging operation, fine needle aspiration [FNA]) and are
             pathologically negative will be eligible

          -  Patients with a history of other invasive malignancies, with the exception of
             non-melanoma skin cancer, are excluded if there is any evidence of other malignancy
             being present within the last 5 years; patients are excluded if their previous cancer
             treatment contraindicates this protocol therapy; specifically, patients who have
             received prior radiotherapy directed to treat disease within the abdominal cavity or
             pelvis are excluded

          -  Prior radiation of localized cancer of the breast, head and neck, thyroid, or skin is
             permitted, provided that it was completed more than 5 years prior to registration, and
             the patient remains free of recurrent or metastatic disease

          -  Patients may have received prior adjuvant chemotherapy for localized breast cancer,
             provided that it was completed more than 5 years prior to registration, and the
             patient remains free of recurrent or metastatic disease

          -  Patients who have contraindications to pelvic radiation therapy (RT) (e.g. pelvic
             kidney, connective tissue disease, inflammatory bowel disease, etc.) should be
             screened in advance and not be considered eligible for the trial

          -  Patients with recurrent endometrial cancer

          -  Patients with surgical or clinical, FIGO 2009 stage III or IV endometrial carcinoma

          -  Patients with non-epithelial uterine malignancies such as uterine carcinosarcoma or
             leiomyosarcoma