A Study of Short-Course Radiation Therapy With Chemotherapy in People With Endometrial Cancer

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Intensity-modulated radiation therapy
  • Carboplatin
  • Paclitaxel

Treatment groups

28 Participants
are divided into 1 treatment group