Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery

NCT ID: NCT00002807

Last Updated: 2020-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-07-04
• Study Completion Date: 2009-12-21

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.

Conditions

Endometrial Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Observation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Radiation

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

Group Type: EXPERIMENTAL

radiation therapy

Intervention Type: RADIATION

45 Gy in 25 fractions over 5 weeks

Interventions

radiation therapy

45 Gy in 25 fractions over 5 weeks

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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

• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Himu R. Lukka, MD

Role: STUDY_CHAIR

Margaret and Charles Juravinski Cancer Centre

Timothy J. Whelan, MD

Role: STUDY_CHAIR

Margaret and Charles Juravinski Cancer Centre

Locations

St. Mary's - Duluth Clinic Cancer Center

Duluth, Minnesota, United States

Royal Women's Hospital

Carlton, Victoria, Australia

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

Fraser Valley Cancer Centre at British Columbia Cancer Agency

Surrey, British Columbia, Canada

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, Canada

Doctor Leon Richard Oncology Centre

Moncton, New Brunswick, Canada

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, Canada

Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Northeastern Ontario Regional Cancer Centre

Greater Sudbury, Ontario, Canada

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, Canada

Cancer Centre of Southeastern Ontario

Kingston, Ontario, Canada

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, Canada

Regional Cancer Care at Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Humber River Regional Hospital - Weston

Weston, Ontario, Canada

Cancer Care Ontario - Windsor Regional Cancer Centre

Windsor, Ontario, Canada

CHUS-Hopital Fleurimont

Fleurimont, Quebec, Canada

Hopital Charles Lemoyne

Greenfield Park, Quebec, Canada

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

McGill Cancer Centre at McGill University

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, Canada

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Countries

United States; Australia; Canada

References

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.

Reference Type: RESULT

PMID: 19070891 (View on PubMed)

Other Identifiers

CAN-NCIC-EN5

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-V96-0945

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDR0000064915

Identifier Type: OTHER

Identifier Source: secondary_id

EN5

Identifier Type: -

Identifier Source: org_study_id