Status:
TERMINATED
The UPPROACH (Upfront Intensity Modulated Proton Beam Therapy) Approach
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
While there is a consensus that both adjuvant ChT and RT benefit patients with respect to locoregional and distant control, the sequencing of these therapies varies between institutions. Common approa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2024
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04527900
Start Date
February 23 2021
End Date
July 2 2024
Last Update
June 19 2025
Active Locations (4)
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1
Maryland Proton Treatment Center
Baltimore, Maryland, United States, 21201
2
UMMC
Baltimore, Maryland, United States, 21201
3
Central Maryland Radiation Oncology
Columbia, Maryland, United States, 21044
4
Baltimore Washington Medical Center
Glen Burnie, Maryland, United States, 21061