The UPPROACH (Upfront Intensity Modulated Proton Beam Therapy) Approach

Description

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

Conditions

Endometrial Cancer

Study Overview

Study Details

Study overview

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

The "Upproach" Approach: A Phase 2 Study Of Upfront Intensity Modulated Proton Beam Therapy (Impt) And Concurrent Chemotherapy For Post-Operative Treatment In Loco-Regionally Advanced Endometrial Cancer

The UPPROACH (Upfront Intensity Modulated Proton Beam Therapy) Approach

Condition
Endometrial Cancer
Intervention / Treatment

-

Contacts and Locations

Baltimore

Maryland Proton Treatment Center, Baltimore, Maryland, United States, 21201

Baltimore

UMMC, Baltimore, Maryland, United States, 21201

Columbia

Central Maryland Radiation Oncology, Columbia, Maryland, United States, 21044

Glen Burnie

Baltimore Washington Medical Center, Glen Burnie, Maryland, United States, 21061

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Surgery must have included a hysterectomy. Bilateral salpingo-oophorectomy, pelvic lymph node sampling, para-aortic lymph node sampling, and omentectomy are optional
  • 2. Patients will be staged according to FIGO 2009 staging system. Eligibility is defined based on clinical-pathologic features.
  • 3. 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.
  • 4. 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.
  • 5. Patients with a GOG Performance Status of 0, 1, or 2
  • 6. 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)
  • 7. Patients who have signed an approved informed consent and authorization permitting release of personal health information
  • 8. Patients must be 18 years of age or older
  • 1. Patients with leiomyosarcoma
  • 2. 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
  • 3. Patients with recurrent endometrial cancer with gross nodal or vaginal disease requiring high dose radiotherapy, or history of prior chemotherapy
  • 4. 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.
  • 5. Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy
  • 6. Patients with an estimated survival of less than three months
  • 7. Patients with FIGO 2009 Stage IVB endometrial cancer
  • 8. Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Maryland, Baltimore,

Pranshu Mohindra, MD, PRINCIPAL_INVESTIGATOR, University of Maryland/Maryland Proton Treatment Center

Study Record Dates

2028-09-01