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

Sponsor

Washington University School of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05975593

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

108

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Locally 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

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 31, 2023

Anticipated Primary Completion Date :

Aug 31, 2032

Anticipated Study Completion Date :

Aug 31, 2032

Arms and Interventions

Arm	Intervention/Treatment
Cervical Cancer Patients will have blood and tumor collected at various time points throughout participation in the study. Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.
Pancreatic Cancer Patients will have blood and tumor collected at various time points throughout participation in the study. Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.

Outcome Measures

Primary Outcome Measures

Changes in tumor microenvironment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Confirmation of intent to receive definitive intent standard of care radiotherapy for one of the following diagnoses:
Unresectable locally advanced cervical cancer (FIGO stage IB3-IVA)
Borderline resectable or unresectable locally advanced pancreatic cancer (AJCC 8th ed stage IB-IV)
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:

Non-standard histology (such as small cell or adenocarcinoma for cervical cancer or neuroendocrine carcinoma for pancreatic cancer)
Co-enrollment to another therapeutic study examining non-standard of care therapy of any kind
Derangements in coagulation parameters (INR > 1.5 x IULN or aPT > 1.5 x IULN) or known coagulation disorder that would place the patient at an elevated risk for acquisition of biospecimens
Any other issue that might preclude safe acquisition of biospecimens