Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer

Not Recruiting

Trial ID: NCT00807768


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.

Official Title

A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients With High Risk, Early Stage Endometrial Carcinoma

Stanford Investigator(s)

Jonathan S. Berek, MD, MMSc
Jonathan S. Berek, MD, MMSc

Laurie Kraus Lacob Professor


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
   (; 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


radiation: intensity-modulated radiation therapy

drug: carboplatin

drug: paclitaxel

radiation: 3-Dimensional Conformal Radiation Therapy

radiation: Internal Radiation Therapy

other: Laboratory Biomarker Analysis

other: Quality-of-Life Assessment

other: Questionnaire Administration

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

New Trial Alerts