Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
This study is being done to find out how often endometrial cancer recurs after the standard treatment as well as how often the standard treatment results in a lymphedema.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ECOG performance status 0-1 or KPS ≥ 70%
Age ≥ 18 years
Endometrioid adenocarcinoma histologic diagnosis on endometrial biopsy or dilatation and curettage
No evidence of extrauterine disease, or suspicious pelvic lymph nodes, or distant metastases, or cervical invasion on pre-operative conventional imaging studies (Pelvic +/- Abdomen CT or MRI or sonogram, or body PET scan) and physical examination (uterine confined by exam and imaging )
Disqualifiers
Extrauterine disease, or gross lymph node involvement, or cervical invasion suspected on pre-operative imaging studies and physical examination (disease not uterine confined clinical stage > I)
Contraindication for SLN mapping
The planned treatment is not surgery, or the surgical treatment does not include hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy
Hysterectomy
Trial population
Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or a member of the research teams. If the investigator is a member of the treatment team, s/he will screen their patients' medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study. The principal investigators may also screen the medical records of patients with whom they do not have a treatment relationship for the limited purpose of identifying patients who would be eligible to enroll in the study, and to record appropriate contact information in order to approach these patients regarding the possibility of enrolling in the study. Patients identified in this manner would subsequently be approached for study enrollment after consultation with their treating physician.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Physical exam
Other interventionPart 2 participants will be prospectively followed clinically for relapse for 30 months from the date of surgery for physical examination at post-ops visits.
Treatment groups
1,715 Participants
are divided into 2 treatment groupsGroup A: Part 10 interventions
Group B: Part 21 intervention
Trial outcomes
Primary outcomes
1
Incidence of pelvic/non-vaginal recurrence at 36 months
Participants will be assessed every 6 (+/- 2) months for 36 months through routine physical examination
Time frame
36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov