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Duluth, Minnesota 55805

  • Endometrial Cancer

Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

EN5


NCT ID:

NCT00002807


Secondary ID:

CAN-NCIC-EN5


Study Acronym:


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

N/A


Maximum Age:

120 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Canadian Cancer Trials Group


Oversight Authority:

  • Canada: Health Canada
  • United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

116


Enrollment Type:

Actual


Overall Contact Information

Official Name:Himu R. Lukka, MD
Study Chair
Margaret and Charles Juravinski Cancer Centre

Study Dates

Start Date:July 4, 1996
Completion Date:December 21, 2009
Completion Type:Actual
Primary Completion Date:December 2007
Primary Completion Type:Actual
Verification Date:April 2020
Last Changed Date:April 2, 2020
First Received Date:November 1, 1999

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Progression-free survival
Time Frame:2009
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Survival (combined with the ASTEC trial)
Time Frame:2009
Safety Issues:False

Study Interventions

Intervention Type:Radiation
Name:radiation therapy
Description:45 Gy in 25 fractions over 5 weeks
Arm Name:Radiation

Study Arms

Study Arm Type:Experimental
Arm Name:Radiation
Description:Post-operative pelvic radiation therapy (45 Gy in 25 fractions over 5 weeks)
Study Arm Type:No Intervention
Arm Name:Observation

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:NCIC Clinical Trials Group

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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. Review.
PMID:19070891

Data Source: ClinicalTrials.gov

Date Processed: August 04, 2021

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