The UPPROACH (Upfront Intensity Modulated Proton Beam Therapy) Approach

Endometrial Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial 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 approaches include sequential treatment, with 4-6 cycles of ChT followed by RT, sandwich therapy with RT sandwiched between 3 cycles of ChT, or concurrent CRT. Small retrospective studies have shown a benefit with respect to PFS and OS in the sandwich approach, however this has not been replicated in larger studies.

In more recent years, proton beam therapy (PBT) has become an increasingly common modality for the treatment of uterine malignancies and is capable of even more precise dose distributions than photon-based RT due to intrinsic properties of these much heavier particles. Dosimetric/planning studies from other institutions confirm the significant reduction of dose to critical normal tissues like bladder, bowel, rectum, and bone marrow.

Preliminary data from the University of Maryland Medical Center has suggested that IMPT using pencil beam scanning is feasible in patients with endometrial cancer, with only 10% of patients developing grade 2 GI toxicity and no patients developing ≥ grade 3 GI or GU toxicities (abstract under review).

The investigators would like to test the hypothesis that in the postoperative setting, patients with advanced endometrial cancer will be able to complete a course of full dose ChT

• carboplatin and paclitaxel - concurrent with upfront pelvic IMPT. ;

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

• NCT number: NCT04527900
• Study type: Interventional
• Source: University of Maryland, Baltimore
• Contact: Pranshu Mohindra, MD
• Phone: 410-328-6080
• Email: pmohindra@umm.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: February 23, 2021
• Completion date: September 1, 2028