Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer
Condition: Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation; Endometrial Mucinous Adenocarcinoma; Endometrial Squamous Cell Carcinoma; Recurrent Endometrial Clear Cell Adenocarcinoma; Recurrent Endometrial Endometrioid Adenocarcinoma; Recurrent Endometrial Serous Adenocarcinoma; Recurrent Endometrial Undifferentiated Carcinoma; Recurrent Uterine Corpus Cancer
MeSH terms: Carcinoma; Adenocarcinoma; Cystadenocarcinoma, Serous; Carcinoma, Endometrioid; Adenocarcinoma, Clear Cell; Adenocarcinoma, Mucinous; Cystadenocarcinoma; Recurrence
Intervention: 3-Dimensional Conformal Radiation Therapy; Cisplatin; Intensity-Modulated Radiation Therapy; Internal Radiation Therapy
Intervention description: Undergo 3-dimensional conformal radiation therapy; Given IV; Undergo IMRT; Given intracavitarily or interstitially
Intervention MeSH terms: Cisplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: Female
Healthy volunteers: No

Summary:

      This randomized phase II trial studies radiation therapy and cisplatin to see how well they
      work compared with radiation therapy alone in treating patients with endometrial cancer that
      has come back. Radiation therapy uses high-energy x-rays and other types of radiation to kill
      tumor cells. Drugs used in chemotherapy, such as 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. It is not yet known whether giving radiation therapy together
      with cisplatin is more effective than radiation therapy alone in treating patients with
      endometrial cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have undergone complete hysterectomy and bilateral
             salpingo-oophorectomy at the time of original therapy for their uterine carcinoma

          -  Patients must have a biopsy with histologically confirmed diagnosis of recurrent
             endometrial cancer confined to the pelvis and/or vagina and no evidence of extrapelvic
             disease

          -  Patients must have endometrial carcinoma including endometrioid adenocarcinoma,
             adenocarcinoma with squamous differentiation, mucinous adenocarcinoma, squamous cell
             carcinoma, mixed carcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, and
             serous adenocarcinoma histologies

          -  Patients must have no evidence of extrapelvic disease; complete workup staging should
             be performed prior to initiation of therapy to rule-out presence of metastatic
             disease; this should include: computed tomography (CT) scan of the thorax with IV
             contrast, as well as a CT of the pelvis and abdomen with IV and oral (PO) contrast
             performed using multi-detector CT and equal or less than 5 mm slice thickness; if the
             patient is unable to tolerate contrast, then magnetic resonance imaging (MRI) with IV
             gadolinium should be performed; a chest x-ray should be done first, and if abnormal,
             then a CT scan of the chest should be done

          -  Primary surgical debulking before protocol therapy is permissible; this would include
             removal of gross symptomatic disease in the pelvis and/or vagina

               -  Exenterative surgery is not permissible; patients with complete resection of
                  gross recurrent disease are eligible

          -  Patients may have received prior hormone therapy and/or systemic chemotherapy; such
             therapy must have been completed at least 6 months prior to study entry and the
             patient has clear evidence of disease subsequent to such therapy; patients must not
             have received neoadjuvant chemotherapy for the present recurrent disease

          -  Patients must have Gynecologic Oncology Group (GOG) performance status 0, 1, or 2

          -  Patients must have an estimated survival greater or equal to 3 months

          -  Absolute neutrophil count (ANC) >= 1,500/mm^3 , equivalent to Common Toxicity Criteria
             (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 3.0) grade 1

          -  Platelets >= 100,000/mm^3 (CTCAE v 3.0 grade 0-1)

          -  Creatinine =< institutional upper limit normal (ULN), CTCAE v 3.0 grade 0; NOTE: if
             creatinine > ULN, creatinine clearance must be > 50 mL/min

          -  Bilirubin =< 1.5 x ULN (CTCAE v 3.0 grade 1)

          -  Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x ULN (CTCAE v 3.0 grade 0-1)

          -  Alkaline phosphatase =< 2.5 x ULN (CTCAE v 3.0 grade 0-1)

          -  Neuropathy (sensory and motor) =< CTCAE v 3.0 grade 1

          -  Patients with ureteral obstruction must undergo stent or nephrostomy tube placement
             prior to study entry

          -  Patients who have met the pre-entry requirements

          -  Patients must have signed an approved informed consent and Health Insurance
             Portability and Accountability Act (HIPAA) authorization

        Exclusion Criteria:

          -  Patients with evidence of disease outside of the pelvis, including presence of
             positive periaortic or inguino-femoral nodes

          -  Patients who have received previous vaginal, pelvic, or abdominal irradiation

          -  Patients who received chemotherapy directed at the present recurrence

          -  Patients with septicemia or severe infection

          -  Patients who have circumstances that will not permit completion of this study or the
             required follow-up

          -  Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal
             transplantation, that would require modification of radiation fields

          -  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 five years; patients are also excluded if their previous
             cancer treatment contraindicates this protocol therapy

          -  Patients who have undergone complete surgical resection of the recurrent tumor and
             have no evidence of residual disease evaluable clinically and by CT or MRI imaging,
             following resection

          -  Patients who have a significant history of cardiac disease, i.e., uncontrolled
             hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias
             within 6 months of registration

          -  Patients with history of active collagen vascular disease

          -  Patients with GOG performance grade of 3 or 4