Last updated: May 6, 2024
Sponsor: University of Maryland, Baltimore
Overall Status: Active - Recruiting
Phase
2
Condition
Pelvic Cancer
Endometrial Cancer
Vaginal Cancer
Treatment
carboplatin and paclitaxel
pelvic IMPT (Intensity Modulated Proton Therapy)
Clinical Study ID
NCT04527900
HP-00092397
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Surgery must have included a hysterectomy. Bilateral salpingo-oophorectomy, pelviclymph node sampling, para-aortic lymph node sampling, and omentectomy are optional
- Patients will be staged according to FIGO 2009 staging system. Eligibility is definedbased on clinical-pathologic features.
- Patients with endometrioid endometrial cancer with the following:
- Stage IA grade 3 with extensive LVSI
- Stage IB grade 3
- Stage II
- Stage III (A, B, and C)
- Stage IVA who are recommended adjuvant whole pelvic RT (+/- lower para-aortic upto renal hilum) and systemic chemotherapy.
- Patients with clear cell, serous papillary carcinoma, or carcinosarcoma with stagesIA-III who are recommended adjuvant whole pelvic RT (+/- lower para-aortic up to renalhilum) and systemic chemotherapy.
- Patients with a GOG Performance Status of 0, 1, or 2
- Patients with adequate organ function, reflected by the following parameters:
- WBC ≥ 3000/mcl
- Absolute neutrophil count (ANC) ≥ 1000/mcl
- Platelet count ≥ 100,000/mcl
- SGOT, SGPT, and alkaline phosphatase ≤ 2.5 X upper limit of normal (ULN)
- Bilirubin ≤ 1.5 X ULN
- Creatinine ≤ institutional ULN (if serum creatinine > ULN, estimated GFR ≥ 45ml/min)
- Patients who have signed an approved informed consent and authorization permittingrelease of personal health information
- Patients must be 18 years of age or older
Exclusion
Exclusion Criteria:
- Patients with leiomyosarcoma
- Patients with clinically significant pelvic or para-aortic nodal disease, onpost-surgery CT scan, that was not dissected and would require higher boost dose
- Patients with recurrent endometrial cancer with gross nodal or vaginal diseaserequiring high dose radiotherapy, or history of prior chemotherapy
- Patients with a history of prior pelvic/abdominal RT or with history of prior cancertreatment that contraindicates this protocol therapy including history of priorchemotherapy for any other malignancy.
- Patients with a history of serious co-morbid illness or uncontrolled illnesses thatwould preclude protocol therapy
- Patients with an estimated survival of less than three months
- Patients with FIGO 2009 Stage IVB endometrial cancer
- Patients with a history of myocardial infarction, unstable angina, or uncontrolledarrhythmia within 3 months from enrollment
Study Design
Total Participants: 21
Treatment Group(s): 2
Primary Treatment: carboplatin and paclitaxel
Phase: 2
Study Start date:
February 23, 2021
Estimated Completion Date:
September 01, 2028
Study Description
Connect with a study center
Maryland Proton Treatment Center
Baltimore, Maryland 21201
United StatesActive - Recruiting
UMMC
Baltimore, Maryland 21201
United StatesActive - Recruiting
Central Maryland Radiation Oncology
Columbia, Maryland 21044
United StatesActive - Recruiting
Baltimore Washington Medical Center
Glen Burnie, Maryland 21061
United StatesActive - Recruiting
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