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Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery

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ClinicalTrials.gov Identifier: NCT00002807
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

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.


Condition or disease Intervention/treatment Phase
Endometrial Cancer Radiation: radiation therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium
Actual Study Start Date : July 4, 1996
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 21, 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Observation
Experimental: Radiation
Post-operative pelvic radiation therapy (45 Gy in 25 fractions over 5 weeks)
Radiation: radiation therapy
45 Gy in 25 fractions over 5 weeks




Primary Outcome Measures :
  1. Survival (combined with the ASTEC trial) [ Time Frame: 2009 ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2009 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002807


Locations
Show Show 25 study locations
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
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Study Chair: Himu R. Lukka, MD Margaret and Charles Juravinski Cancer Centre
Study Chair: Timothy J. Whelan, MD Margaret and Charles Juravinski Cancer Centre
Publications of Results:
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Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00002807    
Other Study ID Numbers: EN5
CAN-NCIC-EN5 ( Other Identifier: PDQ )
NCI-V96-0945 ( Other Grant/Funding Number: NCI )
CDR0000064915 ( Other Identifier: PDQ )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):
stage I endometrial carcinoma
stage II endometrial carcinoma
endometrial adenocarcinoma
endometrial adenosquamous cell carcinoma
endometrial papillary carcinoma
endometrial clear cell carcinoma
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases