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Trial record 46 of 404 for:    LEVONORGESTREL

Megestrol Acetate or Levonorgestrel-Releasing Intrauterine System in Treating Patients With Atypical Endometrial Hyperplasia or Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT01943058
Recruitment Status : Withdrawn (Lack of funding)
First Posted : September 16, 2013
Last Update Posted : September 10, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Tracking Information
First Submitted Date  ICMJE September 11, 2013
First Posted Date  ICMJE September 16, 2013
Last Update Posted Date September 10, 2014
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2013)
Histologic regression from endometrioid adenocarcinoma or complex atypical hyperplasia to benign endometrium [ Time Frame: Up to 6 months after completion of study treatment ]
Histologic regression will be dichotomized as a binary outcome variable, yes if patients have a confirmed histologic regression at the time of the scheduled biopsy, and no if the histologic regression is not observed regardless of compliance, lost-to-follow-up, or other issues. A contingency table and a bar plot will be used to show the histologic regression rate between the 2 arms. Two-group test of equivalence in proportions will be used to detect whether the histologic regression rate in Arm B is not significantly lower than that in Arm A.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01943058 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2013)
  • Change in weight [ Time Frame: Baseline to up to 6 months after completion of study treatment ]
    Weight gain will be recorded longitudinally at each 3-month clinic visit and body mass index (BMI) will be calculated and analyzed over time. Can be evaluated using chi squared tests, logistic regression, or repeated measures analysis of variance (ANOVA) whenever appropriate.
  • Change in mood ascertained using the self-reported Beck Depression Inventory-Primary Care (BDI-PC) [ Time Frame: Baseline to up to 6 months after completion of study treatment ]
    Can be evaluated using chi squared tests, logistic regression, or repeated measures ANOVA whenever appropriate.
  • Compliance [ Time Frame: Up to 6 months after completion of study treatment ]
    Can be evaluated using chi squared tests, logistic regression, or repeated measures ANOVA whenever appropriate.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 11, 2013)
  • Change in levels of ER stress [ Time Frame: Baseline up to 6 months after completion of study treatment ]
    The changes in the biomarker levels will be examined using scatter plots or tables and paired tests such McNemar test, paired t-test or repeated measures ANOVA whenever appropriate.
  • Changes in levels of tumorigenic biomarkers [ Time Frame: Baseline up to 6 months after completion of study treatment ]
    The changes in the biomarker levels will be examined using scatter plots or tables and paired tests such McNemar test, paired t-test or repeated measures ANOVA whenever appropriate.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Megestrol Acetate or Levonorgestrel-Releasing Intrauterine System in Treating Patients With Atypical Endometrial Hyperplasia or Endometrial Cancer
Official Title  ICMJE A Phase II Head-to-Head Comparison of Fertility-Sparing Approaches to Treat Complex Atypical Hyperplasia of the Edometrium: Megestrol Versus Levonorgestrel-Releasing Intrauterine System (LNG-IUS)
Brief Summary This randomized phase II trial studies how well megestrol acetate or levonorgestrel-releasing intrauterine system works in treating patients with atypical endometrial hyperplasia or endometrial cancer. Progesterone can cause the growth of endometrial cancer cells. Hormone therapy using megestrol acetate or levonorgestrel-releasing intrauterine system may fight endometrial cancer by lowering the amount of progesterone the body makes. It is not yet known whether megestrol acetate is more effective than levonorgestrel-releasing intrauterine system in treating atypical endometrial hyperplasia or endometrial cancer.
Detailed Description

PRIMARY OBJECTIVES:

I. To determine if the levonorgestrel-releasing intrauterine system (IUS) results in histologic regression of the endometrial lesion (complex atypical hyperplasia [CAH] and grade 1 endometrial cancer [EC]) comparable to that achieved with oral megestrol (megestrol acetate).

SECONDARY OBJECTIVES:

I. To compare both the side effect profiles, such as weight gain and mood changes as well as compliance with assigned treatment between the 2 treatment arms.

TERTIARY OBJECTIVES:

I. To describe fertility-related outcomes, ovulation, menstrual pattern and fertility abnormalities determined during usual workup (e.g., semen analysis), pregnancy and delivery within 18-months of treatment.

II. To characterize the incidence of endocrine comorbidities (e.g., hypothyroidism, polycystic ovarian syndrome, and diabetes).

III. To characterize the association of levels of endoplasmic reticular (ER) stress and protein kinase B (Akt)-activation in endometrial samples with clinicopathologic-response to Progestin (therapeutic progesterone) therapy.

OUTLINE:

Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive megestrol acetate orally (PO) twice daily (BID) for up to 18 months in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive levonorgestrel-releasing IUS with continuous release for up to 18 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3 and 6 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atypical Endometrial Hyperplasia
  • Endometrial Adenocarcinoma
  • Recurrent Endometrial Carcinoma
  • Stage IA Endometrial Carcinoma
  • Stage IB Endometrial Carcinoma
  • Stage II Endometrial Carcinoma
  • Stage IIIA Endometrial Carcinoma
  • Stage IIIB Endometrial Carcinoma
  • Stage IIIC Endometrial Carcinoma
  • Stage IVA Endometrial Carcinoma
  • Stage IVB Endometrial Carcinoma
Intervention  ICMJE
  • Drug: megestrol acetate
    Given PO
    Other Names:
    • BDH 1298
    • Maygace
    • Megace
    • Megestil
    • Niagestin
  • Device: levonorgestrel-releasing intrauterine system
    Given IUD
    Other Name: Mirena
  • Other: laboratory biomarker analysis
    Correlative studies
  • Other: questionnaire administration
    Ancillary studies
Study Arms  ICMJE
  • Experimental: Arm A (megestrol acetate)
    Patients receive megestrol acetate PO BID for up to 18 months in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: megestrol acetate
    • Other: laboratory biomarker analysis
    • Other: questionnaire administration
  • Experimental: Arm B (levonorgestrel-releasing IUS)
    Patients receive levonorgestrel-releasing IUS with continuous release for up to 18 months in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Device: levonorgestrel-releasing intrauterine system
    • Other: laboratory biomarker analysis
    • Other: questionnaire administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 9, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2013)
130
Estimated Study Completion Date  ICMJE October 2017
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A histologic diagnosis of complex atypical hyperplasia or grade 1 endometrioid adenocarcinoma of the endometrium diagnoses within 3 months of study enrollment who strongly desire to maintain fertility
  • A diagnosis of endometrioid adenocarcinoma will undergo a magnetic resonance imaging (MRI) scan of the pelvis to rule out deep (> 50%) myometrial invasion and extrauterine metastases
  • A negative urine or serum pregnancy test at the time of enrollment
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

    • Has not undergone a hysterectomy or bilateral oophorectomy; or
    • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
  • Willing and able to consent for treatment with office endometrial biopsies every 3 months
  • Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • A diagnosis of grade 1 endometrioid adenocarcinoma of the endometrium who does not wish to maintain fertility
  • MRI evidence of deep myometrial and/or extrauterine spread
  • Congenital or other structural uterine or tubal abnormality
  • An acute pelvic inflammatory disease or medical conditions, such as, but not limited to acquired immunodeficiency syndrome (AIDS) and chronic immunosuppression, that may be associated with an increased susceptibility to infections
  • Current diagnosis of breast cancer or any other cancer
  • Currently pregnant or breastfeeding
  • Thromboembolic disease, deep vein thrombosis, hypercoagulable state
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01943058
Other Study ID Numbers  ICMJE 5U-12-1
NCI-2013-01725 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
5U-12-1 ( Other Identifier: USC Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Yvonne Lin-Liu University of Southern California
PRS Account University of Southern California
Verification Date September 2014

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