MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

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.

Conditions

• 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

Interventions

OTHER

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.

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

DEVICE

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• The Foundation for Barnes-Jewish Hospital

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Cliff Robinson, M.D. · Washington University School of Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-11

Primary Completion

2032-12-31

Completion

2032-12-31

FDA Device

Yes

Countries

• United States

Study Locations