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SCCA Gynecologic Cancer Clinical Trials

Radiation vs Brachytherapy for Endometrial Carcinoma (GOG 249)
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
Status Conditions Phase Study ID
Recruiting Endometrial Cancer
Fatigue
Neurotoxicity
Phase III GOG 249
NCT00807768
Summary

RATIONALE: 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 or by stopping them from dividing. It is not yet known whether pelvic radiation therapy is more effective than vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with endometrial cancer.

PURPOSE: This randomized phase III trial is studying 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.


Investigator
Benjamin E. Greer, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Multicare Health System, Tacoma WA 253-403-5265  
Olympic Medical Center, Sequim WA 360-683-9895  
Skagit Valley Hospital, Mt. Vernon WA 360-424-2687  
Wenatchee Valley Medical Center, Wenatchee WA 509-665-5800 x5122  
Group Health 206-225-7893  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of endometrial carcinoma, meeting 1 of the following criteria:

    • Stage I-IIA disease with high-intermediate risk factors (e.g., grade 2 or 3 tumor, presence of lymphovascular space invasion, and/or outer half myometrial invasion), meeting 1 of the following criteria:

      • Age ≥ 70 years with 1 risk factor
      • Age ≥ 50 years with 2 risk factors
      • Age ≥ 18 years with 3 risk factors
    • Stage IIB (occult) disease (any histology) with or without risk factors

      • Occult disease is defined as lesions that are identified as an incidental finding after hysterectomy in the absence of gross cervical disease
    • Stage I-IIB (occult) disease with serous or clear cell histology with or without other risk factors
  • Has undergone hysterectomy and bilateral salpingo-oophorectomy (open or laparoscopic approach) with or without pelvic and para-aortic lymphadenectomy within the past 4-12 weeks

    • If nodal dissection was not performed, pelvic and para-aortic nodes must be clinically negative with no evidence of distant disease by post-operative, pre-treatment CT scan/MRI

      • Suspicious nodes that have been biopsied (re-staging surgery, fine-needle aspiration) allowed provided they are pathologically negative
    • No pathologically confirmed spread of disease to pelvic or para-aortic lymph nodes or adnexal structures, gross disease to the cervix, or positive cytologic washings
  • No recurrent disease
  • No surgical or clinical stage III or IV endometrial carcinoma
  • No sarcoma, carcinosarcoma (i.e., malignant mixed mullerian tumor), or non-epithelial uterine malignancies (i.e., leiomyosarcoma of the uterine corpus)

PATIENT CHARACTERISTICS:

  • GOG performance status 0-2
  • ANC ≥ 1,500/mcl
  • Platelet count ≥ 100,000/mcl
  • Serum creatinine normal OR creatinine clearance > 50 mL/min
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • No neuropathy (sensory or motor) > grade 1
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No contraindications to pelvic radiotherapy (e.g., pelvic kidney, connective tissue disease, or inflammatory bowel disease)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior non-surgical therapy for endometrial cancer, including chemotherapy, radiotherapy (e.g., pre-operative or post-operative brachytherapy), hormonal therapy, or biological therapy
  • No prior systemic chemotherapy or radiotherapy for another malignancy
  • No concurrent whole-abdominal, extended-field, or interstitial radiotherapy
  • No concurrent erythropoietin therapy
  • Concurrent enrollment on GOG-0210 (molecular marker study) allowed
Last Updated
April 19, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.