Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04527900
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2020-08-14
Brief Title:
The UPPROACH Upfront Intensity Modulated Proton Beam Therapy Approach
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 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 Dosimetricplanning 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
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 Dosimetricplanning 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None