MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

NCT ID: NCT05975593

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-11

Study Completion Date

2032-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Radiotherapy Chemotherapy Cervical cancer Pancreatic cancer Biospecimen

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

30 cervical cancer patients and 30 pancreatic cancer patients
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Tumor collection via biopsy

Intervention Type OTHER

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 collection

Intervention Type OTHER

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)

Intervention Type 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.

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.

Group Type OTHER

Tumor collection via biopsy

Intervention Type OTHER

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 collection

Intervention Type OTHER

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)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tumor collection via biopsy

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.

Intervention Type OTHER

Blood collection

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

Intervention Type OTHER

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

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DBSI MRI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

The Foundation for Barnes-Jewish Hospital

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cliff Robinson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cliff Robinson, M.D.

Role: CONTACT

Phone: 314-362-8567

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Cliff Robinson, M.D.

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U54CA274318

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202307103

Identifier Type: -

Identifier Source: org_study_id