Ignite Creation Date:
2024-07-17 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468215
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-05
Brief Title:
Fertility Sparing Therapy for Patients With Stage IA G2 Endometrial Cancer
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
Fertility Sparing Therapy for Patients With Stage IA G2 Endometrial Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Endometrial cancer EC is a prevalent gynecological cancer with an escalating global incidence and a decreasing age of onset In the era of precision medicine there is an increasing emphasis on tailoring treatments to different populations to optimize the positive impact of clinical interventions Fertility-sparing therapies FST are gaining popularity for early-stage low-grade endometrial cancer due to mounting evidence supporting favorable oncologic and pregnancy outcomes However consensus regarding the feasibility of fertility-sparing therapy for similar low-risk grade-2 G2 endometrioid adenocarcinoma remains elusive Given the uncertainties surrounding fertility-preserving therapy in patients with moderately differentiated endometrial cancer this study aims to investigate the optimal regimen of fertility-preserving therapy for patients with IAG2
Detailed Description:
This study aims to explore effective treatment options and pregnancy outcomes for G2 EC patients who wish to preserve their fertility It compares the efficacy of monotherapy with progesterone versus combined therapy to determine the best treatment option
This study is a multi-center prospective randomized controlled trial that collects hospital and outpatient records of uterine endometrioid adenocarcinoma patients who undergo fertility-sparing treatment at 10 units from October 2022 The basic items specified in the study are registered
Selection criteria Pathological diagnosis of endometrioid adenocarcinoma G2 MRI or ultrasound confirmed localization of the lesion within the endometrium FIGO FIGO 2009 staging IA age 45 years and those who wish to preserve reproductive function signed informed consent Exclusion criteria Tumor invasion of the muscle layer FIGO FIGO 2009 staging IB or higher tumor differentiation as G1 G3 or non-endometrioid adenocarcinoma coexistence of malignant tumors in other sites contraindications or drug prohibitions for conservative treatment or judged by the investigator to be unsuitable for childbearing Exclusion criteria Violation of the treatment protocol failure to take medication as prescribed affecting the judgment of drug efficacy incomplete data affecting the judgment of efficacy and safety Withdrawal criteria Intolerance of the used drugs or the appearance of serious complications including venous or arterial thromboembolism liver failure renal failure anaphylaxis uterine perforation etc no response to treatment or disease progression during drug therapy when the patient requests termination of treatment
Treatment Plan The treatment plan was randomly divided into two groups Group 1 was a single-drug treatment plan with oral medroxyprogesterone acetate MPA 500mgd or megestrol acetate MA 320mgd Group 2 was a combined treatment plan with oral MPA 500mgdMA 320mgd combined with the placement of levonorgestrel intrauterine system LNG-IUS in the uterus
Since the treatment began each 3-6 months is a course At the end of each course an endometrial biopsy is performed under hysteroscopy to conduct tissue pathological examination and evaluate the treatment effect A vaginal color Doppler ultrasound is performed every month and a pelvic MRI is re-evaluated as needed Additionally a side effect assessment is performed for each course including weight vaginal bleeding breast discomfort gastrointestinal symptoms liver and kidney function and thrombosis
The efficacy assessment is divided into the following categories 1 Complete Response CR 2 Partial Response PR 3 Disease Unresponsive or Stable Disease NCSD 4 Disease Progression PD and 5 Relapse
The main measurement indicator is the time required for the first complete remission The secondary measurement indicators are the one-year complete remission rate the two-year disease recurrence rate the cumulative pregnancy rate pregnancy duration pregnancy outcomes changes in serum indicators and pathological markers
This study is a multi-center prospective randomized controlled trial that collects hospital and outpatient records of uterine endometrioid adenocarcinoma patients who undergo fertility-sparing treatment at 10 units from October 2022 The basic items specified in the study are registered
Selection criteria Pathological diagnosis of endometrioid adenocarcinoma G2 MRI or ultrasound confirmed localization of the lesion within the endometrium FIGO FIGO 2009 staging IA age 45 years and those who wish to preserve reproductive function signed informed consent Exclusion criteria Tumor invasion of the muscle layer FIGO FIGO 2009 staging IB or higher tumor differentiation as G1 G3 or non-endometrioid adenocarcinoma coexistence of malignant tumors in other sites contraindications or drug prohibitions for conservative treatment or judged by the investigator to be unsuitable for childbearing Exclusion criteria Violation of the treatment protocol failure to take medication as prescribed affecting the judgment of drug efficacy incomplete data affecting the judgment of efficacy and safety Withdrawal criteria Intolerance of the used drugs or the appearance of serious complications including venous or arterial thromboembolism liver failure renal failure anaphylaxis uterine perforation etc no response to treatment or disease progression during drug therapy when the patient requests termination of treatment
Treatment Plan The treatment plan was randomly divided into two groups Group 1 was a single-drug treatment plan with oral medroxyprogesterone acetate MPA 500mgd or megestrol acetate MA 320mgd Group 2 was a combined treatment plan with oral MPA 500mgdMA 320mgd combined with the placement of levonorgestrel intrauterine system LNG-IUS in the uterus
Since the treatment began each 3-6 months is a course At the end of each course an endometrial biopsy is performed under hysteroscopy to conduct tissue pathological examination and evaluate the treatment effect A vaginal color Doppler ultrasound is performed every month and a pelvic MRI is re-evaluated as needed Additionally a side effect assessment is performed for each course including weight vaginal bleeding breast discomfort gastrointestinal symptoms liver and kidney function and thrombosis
The efficacy assessment is divided into the following categories 1 Complete Response CR 2 Partial Response PR 3 Disease Unresponsive or Stable Disease NCSD 4 Disease Progression PD and 5 Relapse
The main measurement indicator is the time required for the first complete remission The secondary measurement indicators are the one-year complete remission rate the two-year disease recurrence rate the cumulative pregnancy rate pregnancy duration pregnancy outcomes changes in serum indicators and pathological markers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None