Clinical trial NCT00002807: Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery
Official title: A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Keywords: stage I endometrial carcinoma
stage II endometrial carcinoma
endometrial adenocarcinoma
endometrial adenosquamous cell carcinoma
endometrial papillary carcinoma
endometrial clear cell carcinoma
Lead sponsor: Canadian Cancer Trials Group
Sponsor class: NETWORK
First posted: 2003-01-27
Enrollment: 116
Sex: FEMALE
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Survival (combined with the ASTEC trial)
timeFrame: 2009
Secondary outcomes:
measure: Progression-free survival
timeFrame: 2009
Other outcomes:
Locations:
city: Duluth
country: United States
facility: St. Mary's - Duluth Clinic Cancer Center
state: Minnesota
city: Carlton
country: Australia
facility: Royal Women's Hospital
state: Victoria
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre - Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Surrey
country: Canada
facility: Fraser Valley Cancer Centre at British Columbia Cancer Agency
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency - Vancouver Cancer Centre
state: British Columbia
city: Moncton
country: Canada
facility: Doctor Leon Richard Oncology Centre
state: New Brunswick
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: St. Johns
country: Canada
facility: Newfoundland Cancer Treatment and Research Foundation
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Margaret and Charles Juravinski Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Cancer Centre of Southeastern Ontario
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program at London Health Sciences Centre
state: Ontario
city: Sudbury
country: Canada
facility: Northeastern Ontario Regional Cancer Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Weston
country: Canada
facility: Humber River Regional Hospital - Weston
state: Ontario
city: Windsor
country: Canada
facility: Cancer Care Ontario - Windsor Regional Cancer Centre
state: Ontario
city: Fleurimont
country: Canada
facility: CHUS-Hopital Fleurimont
state: Quebec
city: Greenfield Park
country: Canada
facility: Hopital Charles Lemoyne
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: McGill Cancer Centre at McGill University
state: Quebec
city: Quebec City
country: Canada
facility: Centre Hospitalier Universitaire de Quebec
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre at Pasqua Hospital
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
Study officials:
affiliation: Margaret and Charles Juravinski Cancer Centre
name: Himu R. Lukka, MD
role: STUDY_CHAIR
affiliation: Margaret and Charles Juravinski Cancer Centre
name: Timothy J. Whelan, MD
role: STUDY_CHAIR
References:
citation: ASTEC/EN.5 Study Group; Blake P, Swart AM, Orton J, Kitchener H, Whelan T, Lukka H, Eisenhauer E, Bacon M, Tu D, Parmar MK, Amos C, Murray C, Qian W. 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. 2009 Jan 10;373(9658):137-46. doi: 10.1016/S0140-6736(08)61767-5. Epub 2008 Dec 16.