MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial (METEOR-CRATR)

Washington University School of Medicine1 site in 1 country60 target enrollmentJanuary 11, 2024

ConditionsLocally Advanced Cervical Carcinoma Locally Advanced Cervical Cancer Locally Advanced Pancreas Cancer Locally Advanced Pancreatic Carcinoma Locally Advanced Pancreatic Cancer Cervical Cancer Pancreas Cancer Pancreatic Cancer Cancer of the Cervix Cancer of the Pancreas

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Locally Advanced Cervical Carcinoma
Sponsor: Washington University School of Medicine
Enrollment: 60
Locations: 1
Primary Endpoint: Changes in tumor microenvironment
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a dynamically adjustable prospective longitudinal study designed to capture biospecimen (biopsy, blood, surgical) and multimodal treatment-related data (imaging, dosimetry, clinical) before, during, and after treatment with definitive-intent chemoradiotherapy for patients with locally advanced cervical and pancreatic cancer.

Registry

clinicaltrials.gov

Start Date

January 11, 2024

End Date

December 31, 2032

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Washington University School of Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Confirmation of intent to receive radiotherapy for one of the following diagnoses:
•Cervical cancer
•Pancreatic cancer
•ECOG performance status ≤ 2
•At least 18 years old
•Able to understand and willing to sign an IRB-approved written informed consent document

Exclusion Criteria

•Any issue (medical, anatomic, other) that might preclude safe acquisition of biospecimens at the discretion of the treating physician

Outcomes

Primary Outcomes

Changes in tumor microenvironment

Time Frame: From start of follow-up through completion of follow-up (estimated to be 5 years)

Generalized linear mixed effects models will be first used to capture the changes in the longitudinal values of a single assay output over time for a given biospecimen. Random effects will be used to describe the correlation of repeated measures on the same subject over time.