The UPPROACH (Upfront Intensity Modulated Proton Beam Therapy) Approach
Stopped: SOC changed and low enrollment
United States2 participantsStarted 2021-02-23
Plain-language summary
A phase 2 study with the primary objective of testing treatment compliance of Upfront Intensity Modulated Proton Beam Therapy (IMPT) and Concurrent Chemotherapy (UPPROACH) for Post-operative Treatment in Loco-regionally Advanced Endometrial Cancer is non-inferior to the historic compliance rate of the chemoradiation arm of GOG 258 study
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Surgery must have included a hysterectomy. Bilateral salpingo-oophorectomy, pelvic lymph node sampling, para-aortic lymph node sampling, and omentectomy are optional
✓. Patients will be staged according to FIGO 2009 staging system. Eligibility is defined based on clinical-pathologic features.
✓. Patients with endometrioid endometrial cancer with the following:
✓. Patients with clear cell, serous papillary carcinoma, or carcinosarcoma with stages IA-III who are recommended adjuvant whole pelvic RT (+/- lower para-aortic up to renal 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:
✓. Patients who have signed an approved informed consent and authorization permitting release of personal health information
✓. Patients must be 18 years of age or older
Exclusion criteria
✕. Patients with leiomyosarcoma
✕. Patients with clinically significant pelvic or para-aortic nodal disease, on post-surgery CT scan, that was not dissected and would require higher boost dose
✕. Patients with recurrent endometrial cancer with gross nodal or vaginal disease requiring high dose radiotherapy, or history of prior chemotherapy
. Patients with a history of prior pelvic/abdominal RT or with history of prior cancer treatment that contraindicates this protocol therapy including history of prior chemotherapy for any other malignancy.
✕. Patients with a history of serious co-morbid illness or uncontrolled illnesses that would 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 uncontrolled arrhythmia within 3 months from enrollment