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25 mg administered intravenously, infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses).

Andrés Poveda, Oncologist

Type of Application: Clinical trial of new indication.

Experimental drug: The study dose of temsirolimus will be 25 mg administered intravenously, infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses). Temsirolimus is a selective inhibitor of mTOR (mammalian target of rapamycin). Pharmacotherapeutic group: Protein Kinase Inhibitors; ATC code: L01X E09.

Primary Objective:

* To identify in tumor samples future biomarkers associated with a short term exposure to temsirolimus.
* This is an exploratory clinical study. No efficacy objectives are included in this clinical trial.

Secondary Objectives:

* To estimate the tolerability for all temsirolimus-treated patients throughout the study and up to 28 days after the last dose of temsirolimus.
* To correlate observed changes with the different type of endometrial carcinoma (type I and type II), with regard to proteins related to mTOR (p4EBP1, pS6K1, c-MYC, cyclin D, p27, BAD, p53, Bcl-2 PTEN, pAKT, mTOR),
* To estimate the potential predictive value of some biomarkers (immunostaining for PTEN, pAKT, mTOR), relevant mutations in PTEN, PI3KCA, k-RAS, CTNNB1, and microsatellite instability status.
* To estimate the prognostic value of Ki67 expression after short-term presurgical therapy exposure
* To collect data about the differences in expression profile, assessed by RNA microarrays

POEM STUDY: A Phase IIa Trial in Endometrial Carcinoma With Temsirolimus

"A Phase IIa Pharmacokinetic-pharmacodynamic Study to Confirm the Inhibitory Effect of Temsirolimus, Targeting the mTOR Pathway in Endometrial Carcinoma"

To evaluate the mTOR inhibitor effects, assessed by level 4EBP1 and S6K1, of temsirolimus directly on endometrial tumor tissue after four weeks of therapy.

To evaluate if mTOR inhibition is associated with changes in tumor-tissue:

* Signal transduction: AKT and PTEN
* c-MYC, cyclin D activity
* Proliferation index analysis: p53, p27, BAD, Bcl-2 and ki-67

MedSIR

Reproductive Control Agents

Central Nervous System Stimulants

Hormones

Tin Fluorides

Megestrol

Megestrol Acetate

Leuprolide

Goserelin

Levonorgestrel

Triptorelin Pamoate

Dydrogesterone

Progesterone

Contraceptive Agents

Medroxyprogesterone Acetate

Medroxyprogesterone

Contraceptives, Oral

Contraceptives, Oral, Combined

Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor invades less than one half of the myometrium.

Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor is limited to the endometrium.

Patients will receive medroxyprogesterone acetate ("FARLUTAL") 250-500mg/d or megestrol acetate ("YiLiZhi") 160-320mg/d orally. If there is no response after 6 months of treatment, change the regimen to levonorgestrel intrauterine system ("Mirena") and gonadotropin-releasing hormone agonist ("Leuprorelin", "Goserelin" or "Triptorelin") 3.75mg/28d injection subcutaneously. After complete remission, the same regimen will be used for consolidation treatment for another 1-3 months. Subsequently, if the patient has no intention of pregnancy, render maintenance treatment ("Mirena", "Progesterone", "Dydrogesterone", or combined oral contraceptive). Otherwise, the patient will be encouraged to conceive either by an expectation for 3-6 months, or by assisted reproductive technology. Indications for stopping fertility-sparing therapy: 1) disease progression; 2) no response after 9 months of treatment; 3) repeated recurrence; 4) no longer require sparing fertility; 5) serious adverse reactions.

Indication-extended Fertility-sparing Therapy

Jianliu Wang, Professor

The goal of this clinical trial is to explore the feasibility and outcome of fertility-sparing therapy in Stage IA G1-G2 Endometrial Cancer with less than 1/2 myometrial invasion. Researchers will render participants indication-extended fertility-sparing therapy. Researchers will compare the myometrial invasion group with the no myometrial invasion group to see if it is possible to propose an extension indication of fertility-sparing therapy for endometrial cancer.

The study population is patients with Stage IA endometrial adenocarcinoma with no myometrial invasion or less than 1/2 myometrial invasion. The sample size is 57 cases (Myometrial invasion group : No myometrial invasion group = 1 : 2). Follow up every 3-6 months until the end of the fifth year of treatment. The primary outcome measure is the complete remission rate after 9 months of treatment. Secondary outcome measures include complete remission rate (6 months/12 months after initial treatment), complete remission time, recurrence rate (1 year/2 years after complete remission), recurrence time, pregnancy rate (1 year after complete remission), pregnancy outcome, blood molecular biomarkers, pathological markers, adverse reactions, etc.

Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer

Establishment of a Network Platform for Fertility-sparing in Patients With Endometrial Cancer and Study on Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer.

No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.

Time required to achieve complete remission.

After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs.

Time of recurrence after complete remission.

A pregnancy test shows pregnancy after complete remission.

The live birth rate is defined as the ratio of live births to pregnancies.

Used as a tumor marker for disease monitoring.

Homeostasis model assessment of insulin resistance is used as an indicator to evaluate the level of insulin resistance.

Immunohistochemical analysis is used to assess the expression of Ki-67, ER/PR, p53, PTEN, and mismatch repair proteins (MLH1, PMS2, MSH2, and MSH6).

Harmful reactions unrelated to the purpose of treatment occur during normal prevention, diagnosis, and treatment of diseases.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
POEM STUDY: A Phase IIa Trial in Endometrial Carcinoma With Temsirolimus	NCT02093598	Carcinoma, Endo... mTOR Protein	Temsirolimus	18 Years -	MedSIR
Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer	NCT05945407	Endometrial Neo... Endometrial Neo... Endometrial Neo... Carcinoma, Endo... Fertility Prese...	Indication-exte...	18 Years - 45 Years	Peking University People's Hospital

Spots Global Cancer Trial Database for carcinoma, endometrioid