Radiation Therapy or Observation Only in Treating Patients With Endometrial Cancer Who Have Undergone Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00002807
First received: November 1, 1999
Last updated: September 20, 2012
Last verified: April 2012

November 1, 1999
September 20, 2012
July 1996
March 2007   (final data collection date for primary outcome measure)
Survival (combined with the ASTEC trial) [ Time Frame: 2009 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00002807 on ClinicalTrials.gov Archive Site
Progression-free survival [ Time Frame: 2009 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Radiation Therapy or Observation Only in Treating Patients With Endometrial Cancer Who Have Undergone Surgery
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Endometrial Cancer
Radiation: radiation therapy
45 Gy in 25 fractions over 5 weeks
  • No Intervention: Observation
  • Experimental: Radiation
    Post-operative pelvic radiation therapy (45 Gy in 25 fractions over 5 weeks)
    Intervention: Radiation: radiation therapy
The ASTEC/EN.5 writing committee on behalf of the ASTEC/EN.5 Study Group. 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. 2008 Dec 12; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
December 2009
March 2007   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada
 
NCT00002807
EN5, CAN-NCIC-EN5, NCI-V96-0945, CDR0000064915
Yes
NCIC Clinical Trials Group
NCIC Clinical Trials Group
Not Provided
Study Chair: Himu R. Lukka, MD Margaret and Charles Juravinski Cancer Centre
Study Chair: Timothy J. Whelan, MD Margaret and Charles Juravinski Cancer Centre
NCIC Clinical Trials Group
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP