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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00002807




Registration number
NCT00002807
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
6/04/2020

Titles & IDs
Public title
Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery
Scientific title
A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium
Secondary ID [1] 0 0
CAN-NCIC-EN5
Secondary ID [2] 0 0
EN5
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - radiation therapy

No intervention: Observation -

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


Treatment: Other: radiation therapy
45 Gy in 25 fractions over 5 weeks
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival (combined with the ASTEC trial)
Timepoint [1] 0 0
2009
Secondary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
2009

Eligibility
Key inclusion 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
Minimum age
No limit
Maximum age
120 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/07/1996
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/12/2009
Sample size
Target
Accrual to date
Final
116
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Women's Hospital - Carlton
Recruitment postcode(s) [1] 0 0
3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Minnesota
Country [2] 0 0
Canada
State/province [2] 0 0
Alberta
Country [3] 0 0
Canada
State/province [3] 0 0
British Columbia
Country [4] 0 0
Canada
State/province [4] 0 0
New Brunswick
Country [5] 0 0
Canada
State/province [5] 0 0
Newfoundland and Labrador
Country [6] 0 0
Canada
State/province [6] 0 0
Nova Scotia
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Canada
State/province [9] 0 0
Saskatchewan

Funding & Sponsors
Primary sponsor type
Other
Name
NCIC Clinical Trials Group
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00002807
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Himu R. Lukka, MD
Address 0 0
Margaret and Charles Juravinski Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00002807