The UPPROACH (Upfront Intensity Modulated Proton Beam Therapy) Approach

Prior treatment

• Patients with recurrent endometrial cancer with gross nodal or vaginal disease requiring high dose radiotherapy, or history of prior chemotherapy

Other illness

• 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 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 FIGO 2009 Stage IVB endometrial cancer
• Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment

Other

• Patients with leiomyosarcoma
• Patients with an estimated survival of less than three months

• 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:
  • 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 up to renal hilum) and systemic chemotherapy.
• 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:
  • 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 ≥ 45 ml/min)
• 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