Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery

April 2, 2020 updated by: NCIC Clinical Trials Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival (combined with the ASTEC trial)
Time Frame: 2009
2009

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 2009
2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NCIC Clinical Trials Group

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 1996

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 21, 2009

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

April 6, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EN5
  • CAN-NCIC-EN5 (Other Identifier: PDQ)
  • NCI-V96-0945 (Other Grant/Funding Number: NCI)
  • CDR0000064915 (Other Identifier: PDQ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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