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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 (GOG 0258) (CIRB)

Conditions

Corpus Uteri | Endometrial Cancer

Trial Phase

Phase III

Trial Purpose and Description

Trial Purpose

A Randomized PhIII Trial of Cisplatin & Tumor Volume Directed Irradiation Followed by Carboplatin & Paclitaxel vs. Carboplatin & Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma


Participation Guidelines

Age:
18 Years and older
Gender:
Female

Eligibility 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 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
Sponsor:
Gynecologic Oncology Group
Dates:
10/28/2009
Last Updated:
Study HIC#:
0910005816