Radiation Therapy or Observation Only in Treating Patients With Endometrial Cancer Who Have Undergone Surgery - Full Text View

Sponsor:	NCIC Clinical Trials Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002807

Purpose

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	Intervention	Phase
Endometrial Cancer	Procedure: adjuvant therapy Procedure: conventional surgery Procedure: laparoscopic surgery Radiation: brachytherapy Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Survival (combined with the ASTEC trial) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	July 1996

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

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002807

Locations

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

The ASTEC/EN.5 writing committee on behalf of the ASTEC/EN.5 Study Group. 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. 2008 Dec 12; [Epub ahead of print]

Study ID Numbers:	CDR0000064915, CAN-NCIC-EN5, NCI-V96-0945
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00002807 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I endometrial carcinoma
stage II endometrial carcinoma
endometrial adenocarcinoma

endometrial adenosquamous cell carcinoma
endometrial papillary carcinoma
endometrial clear cell carcinoma

Additional relevant MeSH terms:

Genital Diseases, Female
Neoplasms
Endometrial Neoplasms
Neoplasms by Site
Immunologic Factors
Physiological Effects of Drugs

Adjuvants, Immunologic
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010