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Endometrial CancerNCT00002807

Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery

A study testing radiation therapy in people with Endometrial Cancer, run by NCIC Clinical Trials Group at 25 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 120 years, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
25 sitesin 3 countries
Study dates
4 Jul 1996to 21 Dec 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 120 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

25 sites in 3 countries.

25 sites in 3 countries

Canada23 sites

  • Tom Baker Cancer Centre - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Northeastern Ontario Regional Cancer Centre

    Greater Sudbury, Ontario, P3E 5J1

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1

  • Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Cancer Centre of Southeastern Ontario

    Kingston, Ontario, K7L 5P9

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Doctor Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L-4M1

  • McGill Cancer Centre at McGill University

    Montreal, Quebec, H2W 1S6

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Newfoundland Cancer Treatment and Research Foundation

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Fraser Valley Cancer Centre at British Columbia Cancer Agency

    Surrey, British Columbia, V3V 1Z2

  • Regional Cancer Care at Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario, P7B 6V4

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • Humber River Regional Hospital - Weston

    Weston, Ontario, M9N 1N8

  • Cancer Care Ontario - Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

Other trials in Canada

United States1 site

  • St. Mary's - Duluth Clinic Cancer Center

    Duluth, Minnesota, 55805

Other trials in United States

Australia1 site

  • Royal Women's Hospital

    Carlton, Victoria, 3053

Other trials in Australia

About this study

Official title: 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.

Read the 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.

Being tested
radiation therapy
Keywords
stage I endometrial carcinoma, stage II endometrial carcinoma, endometrial adenocarcinoma, endometrial adenosquamous cell carcinoma, endometrial papillary carcinoma, endometrial clear cell carcinoma
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiation therapyRadiation

    45 Gy in 25 fractions over 5 weeks

Study groups in NCT00002807
Study groupRoleWhat they receive
ObservationNo interventionNot described
RadiationExperimentalPost-operative pelvic radiation therapy (45 Gy in 25 fractions over 5 weeks)
Receives: Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival (combined with the ASTEC trial)

    Measured: 2009

Secondary outcomes (1)

  1. Progression-free survival

    Measured: 2009

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study start4 Jul 1996
  3. Primary completionDec 2007
  4. Study completion21 Dec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002807
Sponsor's protocol ID
EN5
Other IDs
CAN-NCIC-EN5, NCI-V96-0945, CDR0000064915
Status last verified
Apr 2020
First submitted
1 Nov 1999
Last updated
6 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 19070891

Questions about this trial

What is this clinical trial studying?

A study testing radiation therapy in people with Endometrial Cancer, run by NCIC Clinical Trials Group at 25 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Canada, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (combined with the ASTEC trial) (time frame: 2009). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002807, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.

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