Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Radiation Therapy or Observation Only in Treating Patients With Endometrial Cancer Who Have Undergone Surgery

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known whether radiation therapy is more effective than observation only after sugery in treating endometrial cancer.
  PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to observation only in treating patients with stage I or stage II endometrial cancer who have undergone hysterectomy and oophorectomy.

Detailed description: OBJECTIVES:
  -  Compare the overall survival in patients with intermediate-risk endometrial cancer treated with pelvic radiotherapy vs observation after laparoscopically-assisted vaginal hysterectomy or total abdominal hysterectomy and bilateral salpingo-oophorectomy.
  -  Compare the time to locoregional recurrence (i.e., in the vaginal mucosa or elsewhere in the central pelvic area or lateral pelvic walls) in patients treated with these regimens.
  -  Compare the duration of ultimate pelvic control and event-free survival in patients treated with these regimens.
  -  Compare the toxic effects of these regimens in these patients.
  -  Compare the quality of life of patients treated with these regimens.
  -  Compare sexual health issues in patients treated with these regimens.
  OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, tumor grade (1 vs 2 vs 3), surgical staging (yes vs no), and sexual health assessment (yes vs no).
  Patients undergo laparoscopic-assisted vaginal hysterectomy or total abdominal hysterectomy and bilateral salpingo-oophorectomy. After surgery, patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients undergo observation alone.
  -  Arm II: Beginning within 12 weeks (preferably within 6-8 weeks) after surgery, patients undergo radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Protocol-defined brachytherapy is allowed.
  Quality of life is assessed at baseline; at 16-18 weeks after surgery (arm I) or 5 and 9 weeks after initiating radiotherapy (arm II); and then at 6, 12, 18, 24, 36, 48, and 60 months.
  Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven adenocarcinoma or adenosquamous cell carcinoma of the endometrium
  -  Intermediate-risk of recurrence after laparoscopically-assisted vaginal hysterectomy (with or without laparoscopic staging) or total abdominal hysterectomy and bilateral salpingo-oophorectomy
  -  Postoperative pathologic stage IA/IB (grade 3), stage IC (grade 1-3), or stage IIA (all grades)
  -  Patients with more than 50% myometrial invasion (grade 1 or 2) or less than 50% myometrial invasion (grade 3) but with positive peritoneal cytology also eligible
  -  Patients whose sole criterion for increased risk is positive peritoneal cytology are not eligible
  -  No pathologically involved lymph nodes if staging procedure performed
  -  Stage I papillary serous or clear cell endometrial cancer allowed
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Performance status:
  -  ECOG 0-3
  Life expectancy:
  -  At least 3 years
  Hematopoietic:
  -  WBC at least 2,000/mm^3
  -  Platelet count at least 100,000/mm^3
  -  Hemoglobin at least 10 g/dL
  Hepatic:
  -  Not specified
  Renal:
  -  Creatinine less than 2 times upper limit of normal
  -  No serious renal disease that would preclude radiotherapy
  Cardiovascular:
  -  No serious cardiovascular disease that would preclude radiotherapy
  Other:
  -  No history of inflammatory bowel disease such as ulcerative colitis
  -  No other malignancy within past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, colon cancer, or thyroid cancer
  -  No psychiatric or addictive disorder that would preclude study participation
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  No prior anticancer hormonal therapy
  -  No concurrent progestogens
  Radiotherapy:
  -  No prior pelvic irradiation
  -  No prior or other concurrent vaginal intracavitary radiotherapy
  Surgery:
  -  See Disease Characteristics
  Other:
  -  No prior anticancer therapy
  -  No other concurrent anticancer therapy

Relevance to patient case: not relevant