Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at La Jolla, California
Dates
study started
estimated completion
Principal Investigator
by Loren K Mell, MD
Headshot of Loren K Mell
Loren K Mell

Description

Summary

  1. To compare acute toxicity and chemotherapy delivery for atlas-based IG-IMRT vs. PET/CT-based IG-IMRT vs. conventional RT, and assess the impact of treatment on changes in hematopoietic compensatory response. 2. To develop and validate machine learning and radiomics techniques for dose accumulation, automated treatment planning, and prediction of treatment response.

Details

This is a grant to conduct correlative science associated with an ongoing NCI-sponsored multi-center cooperative group phase 3 trial (NRG-GY006; NCT02466971). Specifically, this R01 grant pertains to Aims 1.3.7 and 1.3.8 of that trial protocol. The primary objective of the NRG-GY006 is to test the hypothesis that the addition of triapine to standard chemoradiation with concurrent cisplatin can improve overall survival relative to the standard of care. Patients are randomized 1:1 between the experimental (i.e., triapine) and control (i.e., standard of care) arms. The present R01 grant seeks to investigate the effect of image-guided intensity modulated radiation therapy (IG-IMRT) relative to conventional RT on normal tissue toxicity and hematopoietic compensatory response. The investigators will compare 3 methods of delivering external beam radiation therapy: conventional 3D conformal radiotherapy (3DRT), positron emission tomography (PET)-based IG-IMRT, and atlas-based IG-IMRT. Patients are not randomized between the 3 types of radiation; rather, sites treat using 3DRT as a default, and are required to undergo additional credentialing for IG-IMRT. Once credentialed for IG-IMRT, sites are allowed only to treat with IG-IMRT in order to mitigate selection bias. Patients treated on the trial using IG-IMRT prior to 5/13/2019 (demarcating the conversion from phase 2 to phase 3) were treated with PET-based IG-IMRT. Patients treated on the trial using IG-IMRT after 5/13/2019 are treated with atlas-based IG-IMRT. Thus, there are potentially 6 groups to compare (2 chemotherapy arms and 3 RT modalities). The specific aims of the grant are as follows: Aim 1A: To test the hypothesis that multi-atlas-based IGRT reduces acute hematologic toxicity and improves chemotherapy delivery compared to conventional RT Aim 1B: To test the hypothesis that multi-atlas-based IGRT results in comparable acute hematologic toxicity and chemotherapy delivery compared to PET-based IGRT Aim 2A: To test the hypothesis that triapine reduces extra-pelvic compensatory hematopoiesis relative to therapy with cisplatin only Aim 2B: To test the hypothesis that IGRT (multi-atlas-based or PET-based) increases pelvic compensatory hematopoiesis relative to conventional radiotherapy Aim 3: To develop and validate a radiomics model for gynecologic cancer treatment outcomes that incorporates whole body imaging biomarkers of the inflammatory state and correlates with the effectiveness of triapine.

Keywords

Gynecologic Cancer Radiation Therapy Radiomics Imaging

Eligibility

You can join if…

Open to females ages 18 years and up

  • Subjects enrolled to the GY006 clinical trial

You CAN'T join if...

  • Anyone not previously enrolled to the GY006 clinical trial

Location

  • University of California, San Diego accepting new patients
    La Jolla California 92093 United States

Lead Scientist at UCSD

  • Loren K Mell, MD
    Professor, Radiation Medicine and Applied Science, Vc-health Sciences-schools. Authored (or co-authored) 164 research publications. Research interests: Personalized Medicine · Clinical Trials · Risk Modeling · Immune System · Imaging · Immunotherapy

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05358600
Study Type
Observational
Participants
Expecting 450 study participants
Last Updated