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Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
radiation therapy
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring stage I endometrial carcinoma, stage II endometrial carcinoma, endometrial adenocarcinoma, endometrial adenosquamous cell carcinoma, endometrial papillary carcinoma, endometrial clear cell carcinoma

Eligibility Criteria

undefined - 120 Years (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • St. Mary's - Duluth Clinic Cancer Center
  • Royal Women's Hospital
  • Tom Baker Cancer Centre - Calgary
  • Cross Cancer Institute
  • Fraser Valley Cancer Centre at British Columbia Cancer Agency
  • British Columbia Cancer Agency - Vancouver Cancer Centre
  • Doctor Leon Richard Oncology Centre
  • Saint John Regional Hospital
  • Newfoundland Cancer Treatment and Research Foundation
  • Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
  • Margaret and Charles Juravinski Cancer Centre
  • Cancer Centre of Southeastern Ontario
  • London Regional Cancer Program at London Health Sciences Centre
  • Northeastern Ontario Regional Cancer Centre
  • Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
  • Princess Margaret Hospital
  • Humber River Regional Hospital - Weston
  • Cancer Care Ontario - Windsor Regional Cancer Centre
  • CHUS-Hopital Fleurimont
  • Hopital Charles Lemoyne
  • Centre Hospitalier de l'Universite de Montreal
  • McGill Cancer Centre at McGill University
  • Centre Hospitalier Universitaire de Quebec
  • Allan Blair Cancer Centre at Pasqua Hospital
  • Saskatoon Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Observation

Radiation

Arm Description

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

Outcomes

Primary Outcome Measures

Survival (combined with the ASTEC trial)

Secondary Outcome Measures

Progression-free survival

Full Information

First Posted
November 1, 1999
Last Updated
April 2, 2020
Sponsor
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00002807
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 4, 1996 (Actual)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 21, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
stage I endometrial carcinoma, stage II endometrial carcinoma, endometrial adenocarcinoma, endometrial adenosquamous cell carcinoma, endometrial papillary carcinoma, endometrial clear cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Observation
Arm Type
No Intervention
Arm Title
Radiation
Arm Type
Experimental
Arm Description
Post-operative pelvic radiation therapy (45 Gy in 25 fractions over 5 weeks)
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
45 Gy in 25 fractions over 5 weeks
Primary Outcome Measure Information:
Title
Survival (combined with the ASTEC trial)
Time Frame
2009
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
2009

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Himu R. Lukka, MD
Organizational Affiliation
Margaret and Charles Juravinski Cancer Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Timothy J. Whelan, MD
Organizational Affiliation
Margaret and Charles Juravinski Cancer Centre
Official's Role
Study Chair
Facility Information:
Facility Name
St. Mary's - Duluth Clinic Cancer Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Royal Women's Hospital
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Tom Baker Cancer Centre - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Fraser Valley Cancer Centre at British Columbia Cancer Agency
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Doctor Leon Richard Oncology Centre
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Newfoundland Cancer Treatment and Research Foundation
City
St. Johns
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Margaret and Charles Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
London Regional Cancer Program at London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Northeastern Ontario Regional Cancer Centre
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Humber River Regional Hospital - Weston
City
Weston
State/Province
Ontario
ZIP/Postal Code
M9N 1N8
Country
Canada
Facility Name
Cancer Care Ontario - Windsor Regional Cancer Centre
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
Country
Canada
Facility Name
CHUS-Hopital Fleurimont
City
Fleurimont
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Hopital Charles Lemoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L-4M1
Country
Canada
Facility Name
McGill Cancer Centre at McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Allan Blair Cancer Centre at Pasqua Hospital
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19070891
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.
Results Reference
result

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Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery

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