Trial Title:
A Study of Short-Course Radiation Therapy With Chemotherapy in People With Endometrial Cancer
NCT ID:
NCT05691010
Condition:
Endometrial Cancer
Stage III Endometrial Cancer
Stage III Endometrial Carcinoma
Endometrial Carcinoma
Endometrial Carcinoma Stage III
Conditions: Official terms:
Carcinoma
Endometrial Neoplasms
Paclitaxel
Carboplatin
Conditions: Keywords:
endometrial cancer
endometrial cancer stage III
endometrial carcinoma stage III
stage III endometrial cancer
stage III endometrial carcinoma
Memorial Sloan Kettering Cancer Center
22-405
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Intensity-modulated radiation therapy
Description:
After cycles 1, 2, 3 or 4 of chemotherapy, patients will receive IMRT to the vaginal cuff
and pelvic lymph nodes with a total dose of 25 Gy delivered in 5 daily fractions of 5 Gy
Arm group label:
Participants with Endometrial Cancer
Other name:
IMRT
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Patients enrolled in this trial will receive chemotherapy with carboplatin IV AUC 5 at
the discretion of the treating investigator plus paclitaxel 175 mg/m2 every 21 days for 6
cycles
Arm group label:
Participants with Endometrial Cancer
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Patients enrolled in this trial will receive chemotherapy with carboplatin IV AUC 5 at
the discretion of the treating investigator plus paclitaxel 175 mg/m2 every 21 days for 6
cycles
Arm group label:
Participants with Endometrial Cancer
Summary:
The purpose of this study is to find out whether short-course radiation therapy (1 week
instead of the usual 5 weeks) with chemotherapy (carboplatin and paclitaxel) is practical
(feasible), meaning that most participants are able to complete the treatment schedule.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have newly diagnosed endometrial carcinoma. The following histologic
subtypes are eligible for inclusion: endometrioid, serous, clear cell,
dedifferentiated/undifferentiated, mixed epithelial, adenocarcinoma not otherwise
specified, and carcinosarcoma.
- Surgery must have included a hysterectomy, bilateral salpingo-oophorectomy, and
pelvic lymph node surgical assessment (sentinel lymph node mapping and/or sampling).
Para-aortic lymph node surgical assessment is optional.
- Patients must have FIGO (2009) stage IIIA or IIIC1 disease (as determined by
surgical staging).
- Patients must consent to testing with MSK-IMPACT part A and are encouraged to
consent to both parts A and C.
- Age ≥ 18 years.
- Patients must have an Karnofsky Performance Status (KPS) ≥ 70 (or ECOG 0 or 1).
- Neurologic function: Neuropathy (sensory and motor) grade ≤ 1.
- No residual gross disease after surgery.
- No prior radiation therapy or chemotherapy for treatment of endometrial cancer.
- No active infection requiring antibiotics, except for uncomplicated urinary tract
infection.
- Patients must have adequate organ function, defined by the following laboratory
results no more than 14 days prior to first study treatment:
- Absolute neutrophil count (ANC) ≥ 1500/mcL
- Platelet count ≥ 100,000/mcL
- AST/ALT ≤ 3X upper limit of normal (ULN)
- Total bilirubin ≤ 1.5X ULN. Patients with known Gilbert's disease and a total
bilirubin ≤ 3X ULN may be enrolled.
- Creatinine ≤ 1.5X ULN
- Entry into study is limited to no more than 12 weeks from the date of surgery.
- Patients with a prior or concurrent malignancy whose natural history or treatment
does not have the potential to interfere with the safety or efficacy assessment of
the investigational regimen are eligible for this trial.
- Patients of childbearing age will by definition have undergone hysterectomy and
bilateral oophorectomy prior to study enrollment.
- Participants must agree not to breastfeed during the study or for 150 days after the
last dose of study treatment.
Exclusion Criteria:
- Patients whose endometrial cancers harbor known pathogenic POLE mutations
- Patients whose endometrial cancers are mismatch repair deficient, as determined by
immunohistochemical staining for MLH1, PMS2, MSH2, and MSH6 and/or MSI-H
- Active inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.
- History or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the trial, interfere with the subject's
participation for the full duration of the trial, or is not in the best interest of
the subject to participate, in the opinion of the treating investigator. This
includes but is not limited to: uncontrolled ventricular arrhythmia, recent (within
90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled
major seizure disorder, unstable spinal cord compression, and superior vena cava
syndrome.
- Patients unfit for pelvic radiation therapy due to the following:
- Has had radiation therapy encompassing >20% of the bone marrow within 2 weeks,
or any radiation therapy within 1 week prior to day 1 of protocol therapy
- Patients with a history of pelvic radiation.
- Patients with a history or current diagnosis of a vesicovaginal, enterovaginal,
or colovaginal fistula.
- Any hematological abnormality or disorder that would be a contraindication to
radiation per the treating physician.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (All protocol activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kalad Alektiar, MD
Phone:
212-639-7981
Facility:
Name:
Memorial Sloan Kettering Monmouth (All protocol activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kaled Alektiar, MD
Phone:
212-639-7981
Facility:
Name:
Memorial Sloan Kettering Bergen (All protocol activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kaled Alektiar, MD, MSc
Phone:
212-639-7981
Facility:
Name:
Memorial Sloan Kettering Commack (All protocol activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kaled Alektiar, MD
Phone:
212-639-7981
Facility:
Name:
Memorial Sloan Kettering Westchester (All protocol activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kaled Alektiar, MD
Phone:
212-639-7981
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kaled Alektiar, MD
Phone:
212-639-7981
Contact backup:
Last name:
Samuel Singer, MD
Phone:
212-639-2164
Facility:
Name:
Memorial Sloan Kettering Nassau (All protocol activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kaled Alektiar, MD
Phone:
212-639-7981
Start date:
January 10, 2023
Completion date:
January 10, 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05691010
http://www.mskcc.org
