Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery

Sponsor

NCIC Clinical Trials Group (Other)

Overall Status

Completed

CT.gov ID

NCT00002807

Collaborator

(none)

116

Enrollment

Locations

Arms

161.6

Actual Duration (Months)

4.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Radiation: radiation therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 4, 1996

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 21, 2009

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Observation
Experimental: Radiation Post-operative pelvic radiation therapy (45 Gy in 25 fractions over 5 weeks)	Radiation: radiation therapy 45 Gy in 25 fractions over 5 weeks

Arm

Intervention/Treatment

No Intervention: Observation

Experimental: Radiation

Post-operative pelvic radiation therapy (45 Gy in 25 fractions over 5 weeks)

Radiation: radiation therapy

45 Gy in 25 fractions over 5 weeks

Outcome Measures

Primary Outcome Measures

Survival (combined with the ASTEC trial) [2009]

Secondary Outcome Measures

Progression-free survival [2009]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Mary's - Duluth Clinic Cancer Center	Duluth	Minnesota	United States	55805
2	Royal Women's Hospital	Carlton	Victoria	Australia	3053
3	Tom Baker Cancer Centre - Calgary	Calgary	Alberta	Canada	T2N 4N2
4	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
5	Fraser Valley Cancer Centre at British Columbia Cancer Agency	Surrey	British Columbia	Canada	V3V 1Z2
6	British Columbia Cancer Agency - Vancouver Cancer Centre	Vancouver	British Columbia	Canada	V5Z 4E6
7	Doctor Leon Richard Oncology Centre	Moncton	New Brunswick	Canada	E1C 8X3
8	Saint John Regional Hospital	Saint John	New Brunswick	Canada	E2L 4L2
9	Newfoundland Cancer Treatment and Research Foundation	St. Johns	Newfoundland and Labrador	Canada	A1B 3V6
10	Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia	Canada	B3H 1V7
11	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
12	Cancer Centre of Southeastern Ontario	Kingston	Ontario	Canada	K7L 5P9
13	London Regional Cancer Program at London Health Sciences Centre	London	Ontario	Canada	N6A 4L6
14	Northeastern Ontario Regional Cancer Centre	Sudbury	Ontario	Canada	P3E 5J1
15	Regional Cancer Care at Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario	Canada	P7B 6V4
16	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
17	Humber River Regional Hospital - Weston	Weston	Ontario	Canada	M9N 1N8
18	Cancer Care Ontario - Windsor Regional Cancer Centre	Windsor	Ontario	Canada	N8W 2X3
19	CHUS-Hopital Fleurimont	Fleurimont	Quebec	Canada	J1H 5N4
20	Hopital Charles Lemoyne	Greenfield Park	Quebec	Canada	J4V 2H1
21	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec	Canada	H2L-4M1
22	McGill Cancer Centre at McGill University	Montreal	Quebec	Canada	H2W 1S6
23	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec	Canada	G1R 2J6
24	Allan Blair Cancer Centre at Pasqua Hospital	Regina	Saskatchewan	Canada	S4T 7T1
25	Saskatoon Cancer Centre	Saskatoon	Saskatchewan	Canada	S7N 4H4

Sponsors and Collaborators

NCIC Clinical Trials Group

Investigators

Study Chair: Himu R. Lukka, MD, Margaret and Charles Juravinski Cancer Centre
Study Chair: Timothy J. Whelan, MD, Margaret and Charles Juravinski Cancer Centre