Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer
Condition: Endometrial Clear Cell Adenocarcinoma; Endometrial Serous Adenocarcinoma; Stage IA Uterine Corpus Cancer AJCC v7; Stage IB Uterine Corpus Cancer AJCC v7; Stage II Uterine Corpus Cancer AJCC v7; Stage IIIA Uterine Corpus Cancer AJCC v7; Stage IIIB Uterine Corpus Cancer AJCC v7; Stage IIIC Uterine Corpus Cancer AJCC v7; Stage IVA Uterine Corpus Cancer AJCC v7
MeSH terms: Adenocarcinoma; Cystadenocarcinoma, Serous; Adenocarcinoma, Clear Cell
Intervention: Carboplatin; Cisplatin; Internal Radiation Therapy; Paclitaxel; Quality-of-Life Assessment; Radiation Therapy
Intervention description: Given IV; Given IV; Undergo brachytherapy; Given IV; Ancillary studies; Undergo radiation therapy
Intervention MeSH terms: Paclitaxel; Cisplatin; Carboplatin; Albumin-Bound Paclitaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 813.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies carboplatin and paclitaxel to see how well they work
      with or without cisplatin and radiation therapy in treating patients with stage I-IVA
      endometrial cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and
      cisplatin, 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. Radiation therapy
      uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after
      surgery may kill any tumor cells that remain after surgery. It is not yet known whether
      carboplatin and paclitaxel are more effective with or without cisplatin and radiation therapy
      in treating patients with endometrial cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients with surgical stage III or IVA endometrial carcinoma per FIGO 2009
             staging criteria including clear cell and serous papillary and undifferentiated
             carcinoma

               -  Surgical stage III disease includes those patients with positive adnexa,
                  parametrial involvement, tumor invading the serosa, positive pelvic and/or
                  para-aortic nodes, or vaginal involvement

               -  Surgical stage IVA patients with bladder or bowel mucosal involvement, but no
                  spread outside the pelvis

          -  Patients with FIGO 2009 surgical stage I or II endometrial clear cell or serous
             carcinoma and with positive peritoneal cytology

          -  Surgery must have included a hysterectomy and bilateral salpingo-oophorectomy; pelvic
             lymph node sampling and para-aortic lymph node sampling are optional

          -  Patients with a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

          -  White blood cell (WBC) >= 3,000/mcl

          -  Absolute neutrophil count (ANC) >= 1,500/mcl

          -  Platelet count >= 100,000/mcl

          -  Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate
             transaminase (SGPT) =< 2.5 x upper limit of normal (ULN)

          -  Alkaline phosphatase =< 2.5 times ULN

          -  Bilirubin =< 1.5 times ULN

          -  Creatinine =< institutional ULN

          -  Patients who have met the pre-entry requirements; testing values/results must meet
             eligibility criteria

          -  Patients who have signed an approved informed consent and authorization permitting
             release of personal health information

          -  Entry into the study is limited to no more than 8 weeks from the date of surgery

        Exclusion Criteria:

          -  Patients with carcinosarcoma

          -  Patients with recurrent endometrial cancer

          -  Patients with residual tumor after surgery (any single site) exceeding 2 cm in maximum
             dimension

          -  Patients who have had pelvic or abdominal radiation therapy

          -  Patients with positive pelvic washings as the only extra-uterine disease are NOT
             eligible if the histology is other than clear cell or papillary serous carcinoma

          -  Patients with a history of other invasive malignancies, with the exception of
             non-melanoma skin cancer, are excluded if there is any evidence of active malignancy
             within the last five years; patients are also excluded if their previous cancer
             treatment contraindicates this protocol therapy

          -  Patients with a history of serious co-morbid illness or uncontrolled illnesses that
             would preclude protocol therapy

          -  Patients with an estimated survival of less than three months

          -  Patients with FIGO 2009 stage IVB endometrial cancer

          -  Patients with parenchymal liver metastases

          -  Patients who have received prior chemotherapy for endometrial cancer

          -  Patients with a history of myocardial infarction, unstable angina, or uncontrolled
             arrhythmia within 3 months from enrollment