MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

Washington University School of Medicine60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Locally Advanced Cervical Carcinoma Locally Advanced Cervical Cancer Locally Advanced Pancreas Cancer Locally Advanced Pancreatic Carcinoma Locally Advanced Pancreatic Cancer

Interventions

Tumor collection via biopsyOTHER

Cervical cancer: Pre-radiation therapy, 1 week after beginning radiation therapy, 3 weeks after beginning radiation therapy, and recurrence. Pancreatic cancer: pre-stereotactic body radiotherapy, 12 weeks after completion of radiotherapy, and recurrence.

Blood collectionOTHER

Cervical cancer: pre-radiation therapy, 1 week after beginning radiation therapy, 3 weeks after beginning radiation therapy, 6 weeks after completing radiation therapy, 12 weeks after completing radiation therapy, and recurrence. Pancreatic cancer: pre-stereotactic body radiotherapy, 6 weeks after completion of radiotherapy, 12 weeks after completion of radiotherapy, surgery (if applicable), and recurrence

Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)DEVICE

Cervical cancer: initial staging, 12 weeks after completing radiation therapy, and recurrence. Pancreatic cancer: initial staging, stereotactic body radiotherapy (SBRT) simulation, 12 weeks after completing radiation therapy, and recurrence. The imaging will be performed when possible.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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.

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