Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma
Information source: Fudan University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endometrial Atypical Hyperplasia; Endometrial Adenocarcinoma
Intervention: Megestrol acetate and metformin (Drug); Megestrol acetate (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Xiaojun Chen Official(s) and/or principal investigator(s): Xiaojun Chen, PhD, Study Chair, Affiliation: Obstetrics & Gynecology Hospital of Fudan University
Overall contact: Xiaojun Chen, PhD, Phone: 862163455050, Email: cxjlhjj@163.com
Summary
The purpose of this study is to see if megestrol acetate plus metformin will be more
effective in returning the endometrial tissue to a normal state than megestrol acetate alone
in patients with endometrial atypical hyperplasia or early stage endometrial adenocarcinoma.
Clinical Details
Official title: Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pathological response rate
Secondary outcome: Toxicity evaluationRate of relapse Rate of pregnancy
Detailed description:
After diagnosed of endometrial atypical hyperplasia(EAH) or type I endometrial cancer(EC) by
dilatation and curettage (D&C) or hysteroscopy, patients will be enrolled. Age, waist
circumstances, blood pressure, basic history of infertility, blood pressure, serum lipid
level and side effects will be collected. Blood tests, including triglycerides, high density
lipoprotein-cholesterol, fasting blood glucose, liver and kidney function will be performed
before treatment to evacuate their metabolic conditions.
Patients are randomized to 1 of 2 treatment groups. Patients will receive metformin 500 mg
by mouth third daily and megestrol acetate 150 mg by mouth daily for 3 months on Arm I.
Patients will receive megestrol acetate 150 mg PO daily for 3 months on Arm II. Then an
hysteroscope will be used to evaluate the endometrial condition, and the findings will be
recorded. For patients with EAH, complete response (CR) is defined as the reversion of
endometrial atypical hyperplasia to proliferative or secretory endometrium; partial response
(PR) is defined as regression to simple or complex hyperplasia without atypia; no response
(NR) is defined as the persistence of the disease; and progressive disease (PD) is defined
as the appearance of endometrial cancer in patients. EAH after treatment will be defined as
PR in patients with EC. Continuous therapies will be needed in PR, NR or PD.
After completion of study treatment, 3 months of maintenance treatment will be recommended
for patients with CR, and they will be followed up for 2 years.
In addition, we've already had a pilot study in 19 patients primarily diagnosed of
endometrial atypical hyperplasia from August 2012 to April 2013. 10 patients were in Arm I
and 9 patients were in Arm II. Metabolic syndrome were evaluated among all subjects. After
treatment, megestrol acetate plus metformin worked better than megestrol acetate alone. But
two arms showed no difference in NR patients, which may suggest metformin just worked as an
antitumor drug more than an insulin sensitizer. More supportive researches are needed to
verify it.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Be between the ages of 18-45 years old
- Primarily have a confirmed diagnosis of endometrial atypical hyperplasia based upon
D&C or hysteroscopy
- OR primarily have a confirmed diagnosis of endometrial adenocarcinoma(G1, low
tumor grade), based upon D&C or hysteroscopy, and three 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
Exclusion Criteria:
- Have a history of serious liver or renal dysfunction
- Have a confirmed diagnosis of malignant tumor in genital system
- Have taken oral contraceptive or other medicine for the treatment of endometrial
hyperplasia in the past 6 months
- Ask for removal of the uterus or other conservative treatment
- serum CA-125 > 35 Um/L
Locations and Contacts
Xiaojun Chen, PhD, Phone: 862163455050, Email: cxjlhjj@163.com
Fudan University Shanghai Cancer Center, Shanghai, Shanghai 200032, China; Recruiting Huaying Wang, PhD, Email: huaying_wang@yahoo.com
Obstetrics and Gynecology Hospital, Fudan University, Shanghai, Shanghai 200011, China; Recruiting Xiaojun Chen, PhD, Phone: 862163455055, Email: cxjlhjj@163.com Bingyi Yang, BD, Phone: 862163455055, Email: xiaomihaoku@163.com Bingyi Yang, BD, Principal Investigator
Shanghai Changning Maternity & Infant Health Hospital, Shanghai, Shanghai, China; Recruiting Chengbin Ma, Email: machenbin@sohu.com
Shanghai Sixth People's Hospital, Shanghai, Shanghai, China; Recruiting Yincheng Teng Zhihong Ai, Email: ai_zhihong@126.com
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China; Recruiting Jianqing Zhu, Phone: +86-0571-88122222 Huafeng Shou, Phone: +86-0571-88122222, Email: hfshou@126.com
Additional Information
Starting date: October 2013
Last updated: April 6, 2015
|