Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Not specified	Other	CAN-NCIC-EN5 NCI-V96-0945, NCT00002807, EN5

Objectives

1. 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.
2. 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.
3. Compare the duration of ultimate pelvic control and event-free survival in patients treated with these regimens.
4. Compare the toxic effects of these regimens in these patients.
5. Compare the quality of life of patients treated with these regimens.
6. Compare sexual health issues in patients treated with these regimens.

Entry 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

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

Patient Characteristics:

Age:

• Not specified

Performance status:

• ECOG 0-3

Life expectancy:

• At least 3 years

Hematopoietic:

• WBC at least 2,000/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A total of 400 patients will be accrued for this study.

Outcomes

Survival (combined with the ASTEC trial)

Progression-free survival

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.

Blake P, Swart AM, Orton J, et al.: Adjuvant external beam radiotherapy in the treatment of endometrial cancer (MRC ASTEC and NCIC CTG EN.5 randomised trials): pooled trial results, systematic review, and meta-analysis. Lancet 373 (9658): 137-46, 2009.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

Himu Lukka, MD, Protocol chair		Ph: 905-387-9495 ext. 64701 Email: himu.lukka@hrcc.on.ca
Timothy Whelan, MD, Protocol co-chair		Ph: 905-387-9711 ext. 64509

Registry Information
Official Title		A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium
Trial Start Date		1996-07-27
Registered in ClinicalTrials.gov		NCT00002807
Date Submitted to PDQ		1996-06-27
Information Last Verified		2005-07-11

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