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A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium


Phase 3
N/A
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival (combined with the ASTEC trial)

Outcome Time Frame:

2009

Safety Issue:

No

Principal Investigator

Himu R. Lukka, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Margaret and Charles Juravinski Cancer Centre

Authority:

Canada: Health Canada

Study ID:

EN5

NCT ID:

NCT00002807

Start Date:

July 1996

Completion Date:

December 2009

Related Keywords:

  • Endometrial Cancer
  • stage I endometrial carcinoma
  • stage II endometrial carcinoma
  • endometrial adenocarcinoma
  • endometrial adenosquamous cell carcinoma
  • endometrial papillary carcinoma
  • endometrial clear cell carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805