RecruitingEarly Phase 1NCT05691010

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

A Feasibility Study of Integrated Delivery of Hypofractionated Pelvic IMRT With Carboplatin and Paclitaxel in Stage III Copy-Number Low and Copy-Number High Subtypes of Endometrial Cancer

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

28 participants

Start Date

Jan 10, 2023

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer Endometrial Carcinoma Stage III Endometrial Cancer Stage III Endometrial Carcinoma Endometrial Carcinoma Stage III

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a shorter, condensed course of radiation therapy combined with chemotherapy in people with endometrial (uterine) cancer that has spread to the lymph nodes or lining of the abdomen after surgery — aiming to provide effective treatment with fewer hospital visits. **You may be eligible if...** - You are 18 or older and have been newly diagnosed with endometrial cancer - You have had a hysterectomy, removal of both ovaries, and lymph node assessment as part of your surgical treatment - Your cancer is FIGO stage IIIA or IIIC1 (spread to nearby lymph nodes or the outer surface of the uterus) - There is no remaining visible cancer after surgery - You have not had prior radiation or chemotherapy for endometrial cancer - You are in reasonably good physical health (KPS ≥ 70 or ECOG 0–1) **You may NOT be eligible if...** - You still have remaining cancer after surgery - You have had prior radiation or chemotherapy for this cancer - Your blood counts, liver, or kidney function are significantly impaired - You have an active infection requiring antibiotics (except for simple urinary tract infections) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONIntensity-modulated radiation therapy

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

DRUGCarboplatin

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

DRUGPaclitaxel

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