Intrauterine Levonorgestrel and Observation or Observation Alone in Preventing Atypical Endometrial Hyperplasia and Endometrial Cancer in Women With Hereditary Non-Polyposis Colorectal Cancer or Lynch Syndrome

NCT00566644 | Terminated Phase 3

• 4 other identifiers: CRUK-POETCDR0000575423EudraCT 2006-001815-30EU-20784
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 20

Brief Summary

RATIONALE: The use of intrauterine levonorgestrel may prevent atypical endometrial hyperplasia and endometrial cancer in women with hereditary non-polyposis colorectal cancer or Lynch syndrome. It is not yet known whether intrauterine levonorgestrel and observation are more effective than observation alone in preventing atypical endometrial hyperplasia and endometrial cancer in women with hereditary non-polyposis colorectal cancer or Lynch syndrome. PURPOSE: This randomized phase III trial is studying intrauterine levonorgestrel and observation to see how well they work compared with observation alone in preventing atypical endometrial hyperplasia and endometrial cancer in women with hereditary non-polyposis colorectal cancer or Lynch syndrome.

Conditions

Endometrial Cancer; Hereditary Non-polyposis Colon Cancer (hmsh2, hmlh1, hpms1, hpms2)

Keywords

endometrial cancer; hereditary non-polyposis colon cancer (hMSH2, hMLH1, hPMS1, hPMS2)

Outcome Measures

Primary Outcomes (1)

• Rate of atypical endometrial hyperplasia or endometrial cancer during the active follow-up period of the study

Interventions

levonorgestrel-releasing intrauterine system DEVICE

questionnaire administration OTHER

observation PROCEDURE

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Proven to carry a pathogenic germline mutation in a DNA mismatch repair gene causing Lynch syndrome (hereditary non-polyposis colorectal cancer) (usually MSH2, MLH1, or MSH6) * Meets both of the following criteria: * Has a family history of Lynch syndrome according to the following Amsterdam or modified Amsterdam criteria: * Three relatives with a Lynch syndrome-related cancer (colorectal, small bowel, endometrial, ovarian, urothelial, or hepatobiliary) * One is a first-degree relative of the other two * Two generations affected * One relative diagnosed before age of 50 * Personal history of colorectal cancer (i.e., a large, villous, or severely dysplastic colorectal adenoma) before the age of 40 OR history of small bowel, hepatobiliary, or urothelial cancer AND has an affected family member with an abnormal tumor immunohistochemistry staining for Lynch syndrome * No active genital malignancy, breast carcinoma, or other estrogen dependent tumor * History of genital malignancy, breast carcinoma, or other estrogen dependent tumor allowed at the discretion of the investigator PATIENT CHARACTERISTICS: * Must have an intact uterus and not planning to undergo a prophylactic hysterectomy * Not pregnant * Not planning to become pregnant within the next 3 years * No abortion resulting in infection within the past 3 months * No pelvic inflammatory disease (PID) within the past 6 months or recurrent PID * No clinically significant submucous myomas requiring treatment * Small subserous or intramural myomas, clinically assessed as insignificant allowed * No known hypersensitivity to the constituents of the Mirena® IUS * No unresolved abnormal cervical smear and/or current cervical dysplasia * No trophoblastic disease with elevated hCG levels * No liver tumor or other acute or severe liver disease * No clinically significant condition or laboratory result that might, in the opinion of the investigator, compromise patient safety, interfere with evaluations, or prevent completion of the study * No other active malignancy * No history of stroke or myocardial infarction * No history of bacterial endocarditis or severe pelvic infection after any prosthetic valve replacement or in patients with an anatomical lesion of the heart PRIOR CONCURRENT THERAPY: * No other concurrent use of intrauterine devices * No concurrent therapy for cancer

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (20)

Basildon University Hospital

Basildon, England, SS16 5NL, United Kingdom

Location

City Hospital - Birmingham

Birmingham, England, B18 7QH, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Queen Elizabeth Hospital

Gateshead-Tyne and Wear, England, NE9 6SX, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Liverpool Women's Hospital

Liverpool, England, LV8 7SS, United Kingdom

Location

Guy's Hospital

London, England, SE1 9RT, United Kingdom

Location

Chelsea Westminster Hospital

London, England, SW10 9NH, United Kingdom

Location

St. Georges, University of London

London, England, SW17 ORE, United Kingdom

Location

Elizabeth Garrett Anderson Hospital

London, England, WC1E 6DH, United Kingdom

Location

St. Mary's Hospital

Manchester, England, M13 0JH, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Great Western Hospital

Swindon, England, SN3 6BB, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

Belfast City Hospital Trust Incorporating Belvoir Park Hospital

Belfast, Northern Ireland, BT8 8JR, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

Location

University Hospital of Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis

Interventions

Observation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Shirley Hodgson, MD

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 30, 2007
• First Posted: December 3, 2007
• Study Start: July 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: August 1, 2009
• Last Updated: July 10, 2013

Record last verified: 2008-10

Locations

GB (20)