High Grade Squamous Intraepithelial NeoplasiaPhase 2NCT00503581
Megestrol in Treating Patients With Endometrial Neoplasia or Endometrial Hyperplasia
A Phase 2 study testing Biopsy, Laboratory Biomarker Analysis and Megestrol Acetate in people with High Grade Squamous Intraepithelial Neoplasia and Stage 0 Uterine Corpus Cancer, run by Gynecologic Oncology Group at 50 sites in United States.
Trial summary
This randomized phase II trial is studying how well megestrol works in treating patients with endometrial neoplasia or endometrial hyperplasia. Estrogen can cause the growth of endometrial cancer cells. Hormone therapy using megestrol may fight endometrial cancer by blocking the use of estrogen by the abnormal cells. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Grade Squamous Intraepithelial Neoplasia, Stage 0 Uterine Corpus Cancer
- What is being tested?
- Biopsy, Laboratory Biomarker Analysis and Megestrol Acetate
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 50 sitesUnited States
- Study dates
- Jul 2007to Jul 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a diagnosis of atypical endometrial hyperplasia (AEH) or endometrial intraepithelial neoplasia (EIN) diagnosed by dilatation and curettage (D\&C), Novak curettage, Vabra aspirate, or Pipelle endometrial biopsy at the enrolling institution within 12 weeks of enrollment
- Patients must desire uterine retention for duration of study (18 months or after 3rd biopsy) if they remain EIN negative (-); patients are allowed to attempt pregnancy after their initial post-treatment biopsy without it being a major protocol violation
- Patients must have a GOG performance status of 0, 1, or 2
- White blood cell (WBC) >= 3000
- Platelets >= 100,000
- Granulocytes >= 1,500
Show all 14Show fewer
- Creatinine =< 2
- Bilirubin =< 1.5 x institutional upper limit normal
- Serum glutamic oxaloacetic transaminase (SGOT) =< 3 x institutional upper limit normal
- Alkaline phosphatase =< 3 x institutional upper limit normal
- Patients of child-bearing potential must have a negative serum pregnancy test prior to starting study drug and prior to each biopsy if capable of becoming pregnant (and at the discretion of the referring physician)
- Patients of childbearing potential must use appropriate non-hormonal contraception while on study medication
- Patients who have met the pre-entry requirements
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
Who cannot join
- Patients with a GOG performance status of 3 or 4
- Patients with recognized endometrial carcinoma
- Patients with current or prior history of breast cancer
- Patients with invasive malignancies, with the exception of nonmelanoma skin cancer who had (or have) any evidence of the other cancer present within the past 5 years or whose previous cancer treatment contraindicates this protocol therapy
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded
Show all 9Show fewer
- Patients who are pregnant or lactating
- Patients with a history of thrombophlebitis, thromboembolic phenomena, or cerebrovascular disorders within the past 5 years
- Patients under 18 years of age
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 sites
Saint Anthony's Health
Alton, Illinois, 62002
Rush - Copley Medical Center
Aurora, Illinois, 60504
State University of New York Downstate Medical Center
Brooklyn, New York, 11203
Southeast Missouri Hospital
Cape Girardeau, Missouri, 63701
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Northwestern University
Chicago, Illinois, 60611
Mount Carmel Health Center West
Columbus, Ohio, 43222
Duke University Medical Center
Durham, North Carolina, 27710
Elkhart Clinic
Elkhart, Indiana, 46514-2098
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514
Elkhart General Hospital
Elkhart, Indiana, 46515
Gynecologic Oncology of West Michigan PLLC
Grand Rapids, Michigan, 49546
Hartford Hospital
Hartford, Connecticut, 06102
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, 60435
Community Howard Regional Health
Kokomo, Indiana, 46904
IU Health La Porte Hospital
La Porte, Indiana, 46350
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, 53097
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360
Columbia Saint Mary's Water Tower Medical Commons
Milwaukee, Wisconsin, 53211
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864
The Hospital of Central Connecticut
New Britain, Connecticut, 06050
Michiana Hematology Oncology PC-Niles
Niles, Michigan, 49120
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, 28374
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, 46563
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Lakeland Hospital
Saint Joseph, Michigan, 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Memorial University Medical Center
Savannah, Georgia, 31404
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, 46601
South Bend Clinic
South Bend, Indiana, 46617
Northern Indiana Cancer Research Consortium CCOP
South Bend, Indiana, 46628
Mercy Hospital Springfield
Springfield, Missouri, 65804
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, 65804
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109
Saint John's Mercy Medical Center
St Louis, Missouri, 63141
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, 63141
Olive View-University of California Los Angeles Medical Center
Sylmar, California, 91342
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
Cancer Care Associates-Midtown
Tulsa, Oklahoma, 74104
Tulsa Cancer Institute
Tulsa, Oklahoma, 74146
Carle Clinic-Urbana Main
Urbana, Illinois, 61801
Michiana Hematology Oncology-PC Westville
Westville, Indiana, 46391
About this study
Official title: A Randomized Phase II Evaluation of Continuous Progestin Therapy vs. Sequential Progestin Therapy in the Treatment of Endometrial Intraepithelial Neoplasia (EIN) From a Referred Cohort of Atypical Endometrial Hyperplasia (AEH) or EIN Patients That Desire Uterine Preservation
This randomized phase II trial is studying how well megestrol works in treating patients with endometrial neoplasia or endometrial hyperplasia. Estrogen can cause the growth of endometrial cancer cells. Hormone therapy using megestrol may fight endometrial cancer by blocking the use of estrogen by the abnormal cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the frequency of complete remission by a central pathology review panel in diagnosed endometrial intraepithelial neoplasia (EIN) patients treated for 24 weeks with oral continuous versus interrupted progestin therapy.
SECONDARY OBJECTIVES:
- To evaluate whether quality of life is superior in patients who take continuous megestrol versus sequential megestrol by evaluating mood, concerns about weight changes and bleeding.
TERTIARY:
- To assess the expression levels of PTEN using immunohistochemistry and to explore the association of PTEN expression levels with patient response to treatment.
II. To assess the expression levels of the hormone receptors ER and PR using immunohistochemistry and to explore the association of ER/PR expression levels with patient response to treatment.
III. To assess histomorphometry and karyometry characteristics of the pre-treatment biopsy in this patient population.
IV. To identify patterns of protein and glycoprotein expression associated with invasive cancer in serum specimens obtained from patients with a diagnosis of atypical endometrial hyperplasia (AEH) or EIN.
- To assess differences in plasma concentrations of megestrol acetate HPLC in this patient population.
VI. To assess patient compliance to their treatment regimen using HPLC.
OUTLINE: Patients are stratified according to the collection method of the initial/intake biopsy (dilatation and curettage vs all other methods). Patients are randomized to 1 of the following treatment regimens:
REGIMEN 1: Patients receive oral megestrol twice daily every day for 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after completing the megestrol treatment.
REGIMEN 2: Patients receive oral megestrol twice daily for two weeks continuously followed by no treatment for two weeks. This course is repeated for a total of 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after the megestrol treatment.
REGIMEN 3: (Closed as of 6/3/2010) Patients do not receive megestrol. At the discretion of the managing physician, patients undergo the re-evaluation biopsy and hysterectomy anytime between 2-20 weeks after enrollment and randomization. Patients undergo biopsy and blood sample collection periodically for immunological and pharmacodynamic studies. Samples are analyzed for presence or absence of myoinvasion or deep myoinvasion in hysterectomy specimens, hormone receptivity status, and to compare PTEN status against treatment via karyometry or morphometry, expression of VEGF and tenascin-C (TN-C) via ELISA, presence of TN-C fragmentation via western immunoblots, additional biomarkers via proteomic analysis, protein and glycoprotein expression patterns via electrophoresis and image analysis, and plasma megestrol concentrations via high-performance liquid chromatography (HPLC). Patients complete the Hospital Anxiety and Depression Scale (HADS) and two items on bleeding and weight gain at baseline and periodically during study. A Treatment Decision Assessment is completed at baseline, and for patients withdrawing from the study, a Study Withdraw Assessment is also completed. There will be no additional follow-up on this study after the patient's hysterectomy.
- Being tested
- Biopsy, Laboratory Biomarker Analysis, Megestrol Acetate, Pharmacological Study, Quality-of-Life Assessment
- Medical subject headings
- Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called Bx
Undergo biopsy
Laboratory Biomarker AnalysisOther
Correlative studies
Megestrol AcetateDrug
Also called 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate, 17.alpha.-Acetoxy-6-methylpregna-4,6-diene-3,20-dione, 6-Dehydro-6-methyl-17.alpha.-acetoxyprogesterone, 6-Methyl-6-dehydro-17.alpha.-acetoxyprogesterone
given orally
Correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Therapeutic Conventional SurgeryProcedure or surgery
undergo hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Regimen 1 (megestrol acetate, surgery) | Experimental | Patients receive oral megestrol twice daily every day for 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after completing the megestrol treatment. Receives: Procedure: Biopsy; Other: Laboratory Biomarker Analysis; Drug: Megestrol Acetate; Other: Pharmacological Study; Other: Quality-of-Life Assessment; Procedure: Therapeutic Conventional Surgery |
| Regimen 2 (megestrol acetate, surgery) | Experimental | Patients receive oral megestrol twice daily for two weeks continuously followed by no treatment for two weeks. This course is repeated for a total of 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after the megestrol treatment. Receives: Procedure: Biopsy; Other: Laboratory Biomarker Analysis; Drug: Megestrol Acetate; Other: Pharmacological Study; Other: Quality-of-Life Assessment; Procedure: Therapeutic Conventional Surgery |
| Regimen 3 (surgery/biopsy) | Active comparator | (Closed as of 6/3/2010) Patients do not receive megestrol. At the discretion of the managing physician, patients undergo the re-evaluation biopsy and hysterectomy anytime between 2-20 weeks after enrollment and randomization. Receives: Procedure: Biopsy; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Other: Quality-of-Life Assessment; Procedure: Therapeutic Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Experience a Response as Determined by a Central Blinded Review of the Three Post Treatment Endometrial
Treated and eligible participants. This study had 0 participants that completed treatment, therefore no analysis was done. Study closed prior to completion. Central blinded review was not performed for any participants in the study.
Measured: Up to 12 months after completion of treatment
Secondary outcomes (1)
Change in Quality of Life (QOL) Evaluated Using the Hospital Anxiety and Depression Scale (HADS) and the Two Items on Bleeding and Weight Gain
Eligible and Treated patients. This study had 0 participants that completed study.
Measured: Baseline to up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for High Grade Squamous Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael Method, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503581
- Sponsor's protocol ID
- GOG-0224
- Other IDs
- NCI-2009-00594, GOG-0224, CDR0000555427, GOG-0224, GOG-0224, GOG-0224, U10CA101165
- Status last verified
- Oct 2020
- First submitted
- 17 Jul 2007
- Last updated
- 3 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Evaluation of Continuous Progestin Therapy vs. Sequential Progestin Therapy in the Treatment of Endometrial Intraepithelial Neoplasia (EIN) From a Referred Cohort of Atypical Endometrial Hyperplasia (AEH) or EIN Patients That Desire Uterine Preservation
- ClinicalTrials.gov ID
- NCT00503581
- Acronym / sponsor ID
- GOG-0224
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2007
- Primary completion
- Jul 2012 (actual)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Posted 14 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial is studying how well megestrol works in treating patients with endometrial neoplasia or endometrial hyperplasia. Estrogen can cause the growth of endometrial cancer cells. Hormone therapy using megestrol may fight endometrial cancer by blocking the use of estrogen by the abnormal cells.
Detailed description
PRIMARY OBJECTIVES:
- To determine the frequency of complete remission by a central pathology review panel in diagnosed endometrial intraepithelial neoplasia (EIN) patients treated for 24 weeks with oral continuous versus interrupted progestin therapy.
SECONDARY OBJECTIVES:
- To evaluate whether quality of life is superior in patients who take continuous megestrol versus sequential megestrol by evaluating mood, concerns about weight changes and bleeding.
TERTIARY:
- To assess the expression levels of PTEN using immunohistochemistry and to explore the association of PTEN expression levels with patient response to treatment.
II. To assess the expression levels of the hormone receptors ER and PR using immunohistochemistry and to explore the association of ER/PR expression levels with patient response to treatment.
III. To assess histomorphometry and karyometry characteristics of the pre-treatment biopsy in this patient population.
IV. To identify patterns of protein and glycoprotein expression associated with invasive cancer in serum specimens obtained from patients with a diagnosis of atypical endometrial hyperplasia (AEH) or EIN.
- To assess differences in plasma concentrations of megestrol acetate HPLC in this patient population.
VI. To assess patient compliance to their treatment regimen using HPLC.
OUTLINE: Patients are stratified according to the collection method of the initial/intake biopsy (dilatation and curettage vs all other methods). Patients are randomized to 1 of the following treatment regimens:
REGIMEN 1: Patients receive oral megestrol twice daily every day for 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after completing the megestrol treatment.
REGIMEN 2: Patients receive oral megestrol twice daily for two weeks continuously followed by no treatment for two weeks. This course is repeated for a total of 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after the megestrol treatment.
REGIMEN 3: (Closed as of 6/3/2010) Patients do not receive megestrol. At the discretion of the managing physician, patients undergo the re-evaluation biopsy and hysterectomy anytime between 2-20 weeks after enrollment and randomization. Patients undergo biopsy and blood sample collection periodically for immunological and pharmacodynamic studies. Samples are analyzed for presence or absence of myoinvasion or deep myoinvasion in hysterectomy specimens, hormone receptivity status, and to compare PTEN status against treatment via karyometry or morphometry, expression of VEGF and tenascin-C (TN-C) via ELISA, presence of TN-C fragmentation via western immunoblots, additional biomarkers via proteomic analysis, protein and glycoprotein expression patterns via electrophoresis and image analysis, and plasma megestrol concentrations via high-performance liquid chromatography (HPLC). Patients complete the Hospital Anxiety and Depression Scale (HADS) and two items on bleeding and weight gain at baseline and periodically during study. A Treatment Decision Assessment is completed at baseline, and for patients withdrawing from the study, a Study Withdraw Assessment is also completed. There will be no additional follow-up on this study after the patient's hysterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regimen 1 (megestrol acetate, surgery) | Experimental | Procedure: Biopsy, Other: Laboratory Biomarker Analysis, Drug: Megestrol Acetate, Other: Pharmacological Study, Other: Quality-of-Life Assessment, Procedure: Therapeutic Conventional SurgeryPatients receive oral megestrol twice daily every day for 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after completing the megestrol treatment. |
| Regimen 2 (megestrol acetate, surgery) | Experimental | Procedure: Biopsy, Other: Laboratory Biomarker Analysis, Drug: Megestrol Acetate, Other: Pharmacological Study, Other: Quality-of-Life Assessment, Procedure: Therapeutic Conventional SurgeryPatients receive oral megestrol twice daily for two weeks continuously followed by no treatment for two weeks. This course is repeated for a total of 24 weeks. Approximately twelve weeks after treatment starts, clinical blood tests are obtained and research serum and plasma collected. Twenty-four weeks constitutes one course of treatment and a pill count is performed during the 12-week f/u visit and at the completion of the treatment course to determine compliance. After progestin therapy the patient has an induced-withdrawal bleed. Patients in this arm undergo a re-evaluation biopsy and hysterectomy a minimum of two weeks and a maximum of eight weeks after the megestrol treatment. |
| Regimen 3 (surgery/biopsy) | Active comparator | Procedure: Biopsy, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Other: Quality-of-Life Assessment, Procedure: Therapeutic Conventional Surgery(Closed as of 6/3/2010) Patients do not receive megestrol. At the discretion of the managing physician, patients undergo the re-evaluation biopsy and hysterectomy anytime between 2-20 weeks after enrollment and randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have a diagnosis of atypical endometrial hyperplasia (AEH) or endometrial intraepithelial neoplasia (EIN) diagnosed by dilatation and curettage (D\&C), Novak curettage, Vabra aspirate, or Pipelle endometrial biopsy at the enrolling institution within 12 weeks of enrollment
- Patients must desire uterine retention for duration of study (18 months or after 3rd biopsy) if they remain EIN negative (-); patients are allowed to attempt pregnancy after their initial post-treatment biopsy without it being a major protocol violation
- Patients must have a GOG performance status of 0, 1, or 2
- White blood cell (WBC) >= 3000
- Platelets >= 100,000
Key exclusion criteria (9 listed)
- Patients with a GOG performance status of 3 or 4
- Patients with recognized endometrial carcinoma
- Patients with current or prior history of breast cancer
- Patients with invasive malignancies, with the exception of nonmelanoma skin cancer who had (or have) any evidence of the other cancer present within the past 5 years or whose previous cancer treatment contraindicates this protocol therapy
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyAlso: BxUndergo biopsy | Procedure or surgery | Regimen 1 (megestrol acetate, surgery), Regimen 2 (megestrol acetate, surgery), Regimen 3 (surgery/biopsy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Regimen 1 (megestrol acetate, surgery), Regimen 2 (megestrol acetate, surgery), Regimen 3 (surgery/biopsy) |
| Megestrol AcetateAlso: 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate, 17.alpha.-Acetoxy-6-methylpregna-4,6-diene-3,20-dione, 6-Dehydro-6-methyl-17.alpha.-acetoxyprogesterone, 6-Methyl-6-dehydro-17.alpha.-acetoxyprogesteronegiven orally | Drug | Regimen 1 (megestrol acetate, surgery), Regimen 2 (megestrol acetate, surgery) |
| Pharmacological StudyCorrelative studies | Other | Regimen 1 (megestrol acetate, surgery), Regimen 2 (megestrol acetate, surgery), Regimen 3 (surgery/biopsy) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Regimen 1 (megestrol acetate, surgery), Regimen 2 (megestrol acetate, surgery), Regimen 3 (surgery/biopsy) |
| Therapeutic Conventional Surgeryundergo hysterectomy | Procedure or surgery | Regimen 1 (megestrol acetate, surgery), Regimen 2 (megestrol acetate, surgery), Regimen 3 (surgery/biopsy) |
Primary outcome
Number of Patients Who Experience a Response as Determined by a Central Blinded Review of the Three Post Treatment Endometrial
Time frame: Up to 12 months after completion of treatment
Treated and eligible participants. This study had 0 participants that completed treatment, therefore no analysis was done. Study closed prior to completion. Central blinded review was not performed for any participants in the study.
1 secondary outcome
Change in Quality of Life (QOL) Evaluated Using the Hospital Anxiety and Depression Scale (HADS) and the Two Items on Bleeding and Weight Gain
Time frame: Baseline to up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Method principal investigator
Gynecologic Oncology Group
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biopsy, Laboratory Biomarker Analysis and Megestrol Acetate in people with High Grade Squamous Intraepithelial Neoplasia and Stage 0 Uterine Corpus Cancer, run by Gynecologic Oncology Group at 50 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Who Experience a Response as Determined by a Central Blinded Review of the Three Post Treatment Endometrial (time frame: Up to 12 months after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.