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Recruiting Phase 1 NCT05819892

Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer

Trial Parameters

Condition Endometrial Cancer
Sponsor M.D. Anderson Cancer Center
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 21
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2023-07-17
Completion 2027-03-01
Interventions
PaclitaxelCarboplatinDostarlimab

Brief Summary

To learn if chemotherapy given in combination with radiation therapy, followed by maintenance therapy, can help to control endometrial cancer. The safety and effects of this study treatment will also be studied

Eligibility Criteria

Inclusion Criteria: Patients are eligible to participate on this study only if they meet all of the following inclusion criteria. 1. Has read and understands the informed consent form (ICF) and has given written informed consent prior to any study procedures 2. Have surgically staged IIIC, pathologically confirmed endometrial cancer of any histologic subtype and be eligible for adjuvant chemoradiation followed by chemotherapy (Note: Surgical staging is defined as total hysterectomy and lymph node assessment.) 3. Enrolled within 8 weeks of surgery and started treatment within 10 weeks of surgery 4. Age ≥ 18 years 5. Performance Status of ECOG 0 or 1 (see Performance Status Criteria) 6. Adequate hematologic function within 14 days prior to enrollment defined as follows: * Hemoglobin ≥ 9 g/dL * Platelets ≥ 100,000/mcl * Absolute neutrophil count (ANC) ≥ 1,500/mcl 7. Adequate renal function within 14 days prior to enrollment defined as follows: Creatinine ≤ 2 x laboratory upper limit of no

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