Letrozole in Uterine Leiomyosarcoma
ConditionUterine Leiomyosarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGOG Foundation
About this trial
This is a clinical trial to test letrozole in patients with uterine leiomyosarcoma. The main question is will treatment with letrozole extend progression-free survival in patients. Patients will receive 2/5 mg of letrozole daily.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient or a legally authorized representative must have signed an approved informed consent and authorization permitting the release of personal health information.
Patient must have histologically confirmed newly diagnosed uterine leiomyosarcoma with disease limited to the uterus (FIGO 2009 Stage I). Submission of pathology report documenting uterine leiomyosarcoma histology is required in the IRT Source Document Portal following randomization.
Patient tumors must express ER positivity by immunohistochemistry (ER expression greater than 10% by immunohistochemistry). ER status test results must be provided at enrollment. Sites are required to report results of ER status testing in the IRT Source Document Portal.
Patient must have completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks from enrollment.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Letrozole
DrugLetrozole 2.5 mg PO daily
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: LetrozoleExperimental treatment 1 intervention
Group B: ObservationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Progression Free Survival
Time frame
Measured from time of enrollment until date of progression or death up 3 years from randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov