Multi-Atlas and Whole Body Radiomics Approaches for Image-Guided Treatment of Gynecologic Cancers

Gynecologic Cancer Clinical Trial

Official title:

Multi-Atlas and Whole Body Radiomics Approaches for Image-Guided Treatment of Gynecologic Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05358600
• Other study ID #: 803277
• Secondary ID: 1R01CA255780-01
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: February 29, 2024

Study information

• Verified date: April 2022
• Source: University of California, San Diego
• Contact: Gerald Henderson, BA
• Phone: 858-534-4811
• Email: gehenderson[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects enrolled to the GY006 clinical trial

Exclusion Criteria:

• Anyone not previously enrolled to the GY006 clinical trial

Related Conditions & MeSH terms

• Gynecologic Cancer

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	National Cancer Institute (NCI), NRG Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Hematologic Toxicity (HT)	Rates of Grade 2+ and 3+ Overall HT, Neutropenia, Leukopenia, Lymphopenia, Thrombocytopenia, and Anemia, by treatment group	Change from Baseline at 1 month post-chemoradiotherapy
Primary	Chemotherapy Delivery	Overall number of cycles of cisplatin, triapine (if applicable) delivered, by treatment group	Change from Baseline at the end of chemoradiotherapy
Primary	Compensatory Hematopoiesis	Change in relative volume of metabolically active bone marrow within (pelvic) and outside of (extra-pelvic) treatment field, measured by serial FDG-PET/CT (equation given in: Noticewala SS, Li N, Williamson CW, et al. Longitudinal Changes in Active Bone Marrow for Cervical Cancer Patients Treated With Concurrent Chemoradiation Therapy. Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):797-805. doi: 10.1016/j.ijrobp.2016.11.033. Epub 2016 Nov 29. PMID: 28244416), by Treatment Group	Baseline to 3-4 months post-chemoradiotherapy
Primary	Progression-Free Survival	Time from randomization to first occurrence of disease recurrence/progression or death from any cause (or censoring), by risk group defined by radiomics model	3 years