Megestrol Acetate Plus LNG-IUS in Young Women With Early Endometrial Cancer

NCT03241914 | Completed Phase 2

• 1 other identifier: 2017-30-2
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

To see if megestrol acetate plus Levonorgestrel-releasing intrauterine system (LNG-IUS) will not be inferior to returning the endometrial tissue to a normal state than megestrol acetate alone in patients with early endometrial cancer.

Conditions

Endometrial Neoplasm Malignant Stage I

Outcome Measures

Primary Outcomes (2)

• Pathological response rate

  From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months

• Pathological response time

  median time of histologic regression from endometrial atypical hyperplasia to benign endometrium

  From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months

Secondary Outcomes (4)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  up to 2 years after the treatment for each patient

• Rate of relapse

  up to 2 years after the treatment for each patient

• Rate of pregnancy

  up to 2 years after the treatment for each patient

• Compliance

  up to 2 years after the treatment for each patient

Other Outcomes (1)

• Economic consequences through study completion

  From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months

Study Arms (2)

MA

ACTIVE COMPARATOR

Patients will receive megestrol acetate 160 mg by mouth daily for at least 3 months.Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.

Drug: Megestrol Acetate

MA+LNG-IUS

EXPERIMENTAL

Patients will receive MA (160mg po qd) plus LNG- IUS insertion for at least 3 months. Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.

Drug: Megestrol Acetate; Device: Levonorgestrel-releasing Intrauterine System(LNG-IUS)

Interventions

Megestrol Acetate DRUG

At a dosage of 160 mg/day

Also known as: Megace

MA; MA+LNG-IUS

Levonorgestrel-releasing Intrauterine System(LNG-IUS) DEVICE

levonorgestrel 52mg. It is a hormone-releasing T-shaped intrauterine system.

Also known as: Mirena Intrauterine Device, Mirena

MA+LNG-IUS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primarily have a confirmed diagnosis of endometrioid endometrial cancer based upon hysteroscopy
• MRI parameters shows there's no myometrial invasion, extension beyond corpus, or enlarged lymph nodes
• Have a desire for remaining reproductive function or uterus
• Need to be able to undergo correlative treatment and follow-up

You may not qualify if:

• Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
• Pregnancy or suspicion of pregnancy
• Have a history of EAH or EC and have disease relapse during Merina insertion
• Under treatment of high-dose progestin therapy more than 3 months in recent 6 months
• Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
• Confirmed diagnosis of malignant tumor in genital system
• Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
• Hypersensitivity or contradiction to any component of this product
• Ask for removal of the uterus or other conservative treatment
• Smoker(\>15 cigarettes a day)

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (1)

• Xu Z, Yang B, Guan J, Shan W, Liao J, Shao W, Chen X. Comparison of the effect of oral megestrol acetate with or without levonorgestrel-intrauterine system on fertility-preserving treatment in patients with early-stage endometrial cancer: a prospective, open-label, randomized controlled phase II trial (ClinicalTrials.gov NCT03241914). J Gynecol Oncol. 2023 Jan;34(1):e32. doi: 10.3802/jgo.2023.34.e32. Epub 2022 Dec 15.

  PMID: 36562136 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Megestrol Acetate

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

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: August 8, 2017
• Study Start: July 4, 2017
• Primary Completion: June 18, 2020
• Study Completion: June 18, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

CN (1)