Phase
Condition
Pelvic Cancer
Vaginal Cancer
Endometriosis
Treatment
carboplatin and paclitaxel
pelvic IMPT (Intensity Modulated Proton Therapy)
Clinical Study ID
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 isdefined based 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-aorticup to 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 torenal hilum) 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
Study Description
Connect with a study center
Maryland Proton Treatment Center
Baltimore, Maryland 21201
United StatesSite Not Available
UMMC
Baltimore, Maryland 21201
United StatesSite Not Available
Central Maryland Radiation Oncology
Columbia, Maryland 21044
United StatesSite Not Available
Baltimore Washington Medical Center
Glen Burnie, Maryland 21061
United StatesSite Not Available

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