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SCCA Gynecologic Cancer Clinical Trials

Combination Chemotherapy + Radiation Therapy for Stage III/IVA Endometrial Cancer (GOG 0258)
A Randomized Phase III Trialof Cisplatin and Tumor Volume Directional Irradiation Followed By Carboplatin and Paclitaxel Vs.for Optimally Debulked, Advanced Endometrial Carcinoma
Status Conditions Phase Study ID
Recruiting Endometrial Cancer Phase III GOG 0258
NCT00942357
Summary

RATIONALE: 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 or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation 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.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel to see how well they work when given with or without cisplatin and radiation therapy in treating patients with stage III or stage IVA endometrial cancer.


Investigator
Benjamin Greer, MD
Location    
PSOC Office 206-667-5152  
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:

  • Histologically confirmed endometrial carcinoma, including the following cell types:

    • Clear cell carcinoma
    • Serous papillary carcinoma
    • Undifferentiated carcinoma

  • Surgical stage III or IVA disease per FIGO 1988 staging criteria

    • Surgical stage III disease includes positive adnexa, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement

      • Positive pelvic washings as only extra-uterine disease allowed provided histology is clear cell or serous papillary carcinoma
    • Surgical stage IVA disease includes bladder or bowel mucosal involvement, but no spread outside the pelvis

  • Has undergone optimal surgical debulking that included a hysterectomy and bilateral salpingo-oophorectomy within the past 8 weeks

    • Residual tumor after surgery (any single site) ≤ 2 cm in maximum dimension
  • No carcinosarcoma
  • No parenchymal liver metastases
  • No recurrent endometrial cancer

PATIENT CHARACTERISTICS:

  • GOG performance status 0-2
  • Life expectancy ≥ 3 months
  • WBC ≥ 3,000/mm^3
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 1.5 times ULN
  • Creatinine ≤ ULN
  • No myocardial infarction, unstable angina, or uncontrolled arrhythmia within the past 3 months
  • No other active invasive malignancy within the past 5 years except for non-melanoma skin cancer
  • No history of serious co-morbid or uncontrolled illness that would preclude study therapy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior pelvic or abdominal radiotherapy
  • No prior chemotherapy for endometrial cancer
  • No prior cancer treatment that would preclude study therapy
Last Updated
March 01, 2013
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.