The UPPROACH (Upfront Intensity Modulated Proton Beam Therapy) Approach

NCT04527900 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: HP-00092397
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 4

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 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

Keywords

Endometrial cancer; Gynecologic cancers; Radiotherapy; Proton Therapy; Chemotherapy; Chemoradiation

Outcome Measures

Primary Outcomes (1)

• Compliance rates

  This will be measured as proportion of patients completing full 6 cycles of chemotherapy concurrently with IMPT

  End of study, approximately 4 years

Secondary Outcomes (7)

• Acute GI and urinary toxicity

  once a week during radiation treatment (5-6 weeks)

• Acute GI and urinary toxicity

  once a week during radiation treatment (5-6 weeks)

• Acute GI and urinary toxicity

  once a week during radiation treatment (5-6 weeks)

• Acute hematologic toxicity

  Prior to each cycle of chemotherapy (once every 21 days for 106 days)

• Late GI and urinary toxicity

  6-month following radiation therapy

Study Arms (1)

Concurrent chemoradiation

EXPERIMENTAL

Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy)

Drug: carboplatin and paclitaxel; Radiation: pelvic IMPT (Intensity Modulated Proton Therapy)

Interventions

carboplatin and paclitaxel DRUG

carboplatin and paclitaxel 5-6 cycles (dosage per standard of care according to treating oncologist)

Concurrent chemoradiation

pelvic IMPT (Intensity Modulated Proton Therapy) RADIATION

whole pelvis will receive a total dose of 4500 cGy in 25 fractions to 5040 cGy in 28 fractions

Concurrent chemoradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (4)

Maryland Proton Treatment Center

Baltimore, Maryland, 21201, United States

Location

UMMC

Baltimore, Maryland, 21201, United States

Location

Central Maryland Radiation Oncology

Columbia, Maryland, 21044, United States

Location

Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Pranshu Mohindra, MD

  University of Maryland/Maryland Proton Treatment Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 27, 2020
• Study Start: February 23, 2021
• Primary Completion: July 2, 2024
• Study Completion: July 2, 2024
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)