MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

Study Overview
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Brief Summary
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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.

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

Conditions
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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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cervical Cancer<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in tumor microenvironment | 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. | From start of follow-up through completion of follow-up (estimated to be 5 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Chemotherapy, Cervical cancer, Pancreatic cancer, Biospecimen