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GOG 0258

Study #0258

Condition / Intervention

Endometrial Cancer


A randomized phase III trial of cisplatin and tumor volume directed irradiation followed by carboplatin and paclitaxel vs. carboplatin and paclitaxel for optimally debulked, advanced endometrial carcinoma


Sheida Mani, MD

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For more information about this study and to inquire about eligibility, (203) 384-3611

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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 2009 staging criteria
    • Surgical stage III disease includes positive adnexa, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement
    • Surgical stage IVA disease includes bladder or bowel mucosal involvement, but no spread outside the pelvis
  • Surgical stage I or II endometrial clear cell or serous papillary carcinoma with positive peritoneal cytology per FIGO 2009 staging criteria
  • 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 or endometrioid stage I or II with positive peritoneal cytology

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

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