A Study of Short-Course Radiation Therapy With Chemotherapy in People With Endometrial Cancer (NCT05691010) | Clinical Trial Compass
RecruitingEarly Phase 1
A Study of Short-Course Radiation Therapy With Chemotherapy in People With Endometrial Cancer
United States28 participantsStarted 2023-01-10
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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.
* Cr…
What they're measuring
1
Feasibility of integrated delivery of short-course IMRT with carboplatin/paclitaxel in patients with stage III endometrial cancer