TERMINATED

The UPPROACH (Upfront Intensity Modulated Proton Beam Therapy) Approach

Conditions

Endometrial Cancer Gynecologic cancers Radiotherapy Proton Therapy Chemotherapy Chemoradiation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2021-02-23

Study Completion:2024-07-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT04527900

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Pranshu Mohindra, MD

PRINCIPAL_INVESTIGATOR

University of Maryland/Maryland Proton Treatment Center

Study Locations (Sites)

Maryland Proton Treatment Center

Baltimore, Maryland, 21201

United States

UMMC

Baltimore, Maryland, 21201

United States

Central Maryland Radiation Oncology

Columbia, Maryland, 21044

United States

Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-23

Study Completion Date2024-07-02

Study Record Updates

Study Start Date2021-02-23

Study Completion Date2024-07-02

Terms related to this study

Keywords Provided by Researchers

Endometrial cancer
Gynecologic cancers
Radiotherapy
Proton Therapy
Chemotherapy
Chemoradiation

Additional Relevant MeSH Terms

Endometrial Cancer