The UPPROACH (Upfront Intensity Modulated Proton Beam Therapy) Approach

Stopped early · Phase 2

Conditions studied: Endometrial Cancer

In brief

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

Key facts

Study ID

NCT04527900

Run by

University of Maryland, Baltimore

People needed

2

Starts

2021-02-23

Expected to finish

2024-07-02

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Maryland Proton Treatment Center — Baltimore, Maryland, United States
• UMMC — Baltimore, Maryland, United States
• Central Maryland Radiation Oncology — Columbia, Maryland, United States
• Baltimore Washington Medical Center — Glen Burnie, Maryland, United States

Full record on ClinicalTrials.gov

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