Ovarian Cancer Clinical Trial

Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Screening Inclusion Criteria:

ECOG performance status 0-1 or KPS ≥ 70%
Age ≥ 18 years
Endometrioid adenocarcinoma histologic diagnosis on endometrial biopsy or dilatation and curettage confirmed at the enrolling institution
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 )
Suitable candidate for surgery
Planned surgical treatment including hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy
No history of second primary cancer (invasive or in situ) within the past 5 years, not including non-melanoma skin cancer
Approved and signed informed consent
No history of neoadjuvant chemotherapy or radiotherapy for endometrial cancer
No history of prior pelvic or abdominal radiotherapy

Screening Exclusion Criteria:

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

Eligibility Inclusion Criteria

Patients will be classified in the study cohort (part 2; n=182) according to surgical treatment received, final post hysterectomy and staging pathologic report, and planned adjuvant treatment. The inclusion criteria are specified below.

Study Cohort (n=182)

A patient will be enrolled in the study cohort if all the following criteria are met:

At surgery, the patient must undergo:

Hysterectomy
Bilateral salpingo-oophorectomy, unless already previously performed
Bilateral pelvic SLN mapping (bilateral sentinel nodes are negative for malignancy)

On the final pathologic report, the patient must have a diagnosis of:

Stage I intermediate-risk endometrial endometrioid cancer (Grade 1 or Grade 2 with ≥ 50% myometrial invasion or Grade 3 with <50% myometrial invasion, including non-invasive disease)
Negative pelvic peritoneal cytology

Adjuvant treatment as recommended by the multidisciplinary team must be as follows:

No adjuvant treatment, or
Intravaginal radiation only

Eligibility Exclusion Criteria

There is intra-operative detection of extra-uterine disease or grossly involved lymph nodes
Presence of any positive pelvic nodes including micrometastasis and isolated tumor cells (ITC)
Hysterectomy is not performed
Bilateral salpingo-oophorectomy is not performed, unless already previously performed
Failed unilateral or bilateral SLN mapping
Patient undergoes a complete unilateral or bilateral pelvic lymphadenectomy
Patient undergoes a radical type C hysterectomy
Stage IA endometrioid cancer Grade1 or 2 and myometrial invasion <50%
Stage IB Grade 3 endometrioid cancer
Non-endometrioid histology: Serous, clear cell, carcinosarcoma, undifferentiated, or de-differentiated histology noted on final hysterectomy pathology
Empty unilateral or bilateral sentinel lymph nodal packet(s)
Positive peritoneal cytology

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

1400

Study ID:

NCT04291612

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 14 Locations for this study

See Locations Near You

Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford Connecticut, 06102, United States More Info
Jonathan Cosin, MD
Contact
860-826-1101
University of Miami (Data Collection Only)
Miami Florida, 33136, United States More Info
Brian Clomovitz, MD
Contact
305-243-2233
Miami Cancer Institute Baptist Health South Florida
Miami Florida, 33143, United States More Info
John Paul Diaz, MD
Contact
786-596-2000
ADVENTHEALTH (Data collection only)
Orlando Florida, 32804, United States More Info
Robert Holloway, MD
Contact
407-303-2422
Mayo Clinic (Data Collection and Data Analysis)
Rochester Minnesota, 55905, United States More Info
Andrea Mariani, MD
Contact
[email protected]
Memoral Sloan Kettering Basking Ridge (All protocol activities)
Basking Ridge New Jersey, 07920, United States More Info
Nadeem Abu-Rustum, MD
Contact
212-639-7051
Memoral Sloan Kettering Monmouth (All protocol activities)
Middletown New Jersey, 07748, United States More Info
Nadeem Abu-Rustum, MD
Contact
212-639-7051
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale New Jersey, 07645, United States More Info
Nadeem Abu-Rustum, MD
Contact
212-639-7051
Memorial Sloan Kettering Commack (All Protocol Activities)
Commack New York, 11725, United States More Info
Nadeem Abu-Rustum, MD
Contact
212-639-7051
Memoral Sloan Kettering Westchester (All protocol activities)
Harrison New York, 10604, United States More Info
Nadeem Abu-Rustum, MD
Contact
212-639-7051
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Nadeem Abu-Rustum, MD
Contact
212-639-7051
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre New York, 11553, United States More Info
Nadeem Abu-Rustum, MD
Contact
212-639-7051
Lehigh Valley Health Network
Allentown Pennsylvania, 18103, United States More Info
Martin Martino, MD
Contact
610-402-3650
MD Anderson Cancer Center (Data Collection Only)
Houston Texas, 77030, United States More Info
Pamela Soliman, MD
Contact
713-792-2121
Charles University and General University Hospital (Data Collection Only)
Prague , , Czechia More Info
David Cibula,, MD
Contact
224967205
OSPEDALE MICHELE E PIETRO (Data Collection Only)
Ferrera , , Italy More Info
Alessandro Buda, MD
Contact
0173 290851
UNIVERSITY OF MILANO-BICOCCA, ITALY (Data Collection)
Milan , , Italy More Info
Tommaso Grassi, MD
Contact
+39 02 6448 6099
FONDAZIONE POLICLINICOUNIVERSITARIO A. GEMELLI, ITALY (Data Collection Only)
Roma , , Italy More Info
Giovanni Scambia, MD
Contact
39 06 30151
L'Azienda Sanitaria Universitaria Friuli Centrale
Udine , , Italy More Info
Giuseppe Vizzielli, MD
Contact
[email protected]
OSLO UNIVERSITY HOSPITAL,RIKSHOPITALET (Data Collection Only)
Oslo , , Norway More Info
Ane Gerda, MD, PhD
Contact
+47 22 93 44 46

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

1400

Study ID:

NCT04291612

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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