Trial Title:
MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial
NCT ID:
NCT05975593
Condition:
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
Conditions: Official terms:
Carcinoma
Pancreatic Neoplasms
Uterine Cervical Neoplasms
Conditions: Keywords:
Radiotherapy
Chemotherapy
Cervical cancer
Pancreatic cancer
Biospecimen
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
30 cervical cancer patients and 30 pancreatic cancer patients
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Tumor collection via biopsy
Description:
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.
Arm group label:
Cervical Cancer
Arm group label:
Pancreatic Cancer
Intervention type:
Other
Intervention name:
Blood collection
Description:
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
Arm group label:
Cervical Cancer
Arm group label:
Pancreatic Cancer
Intervention type:
Device
Intervention name:
Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)
Description:
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.
Arm group label:
Cervical Cancer
Arm group label:
Pancreatic Cancer
Other name:
DBSI MRI
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) radiotherapy for patients with locally advanced cervical and pancreatic
cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Confirmation of intent to receive standard of care radiotherapy for one of the
following diagnoses:
- Locally advanced or metastatic cervical cancer
- Locally advanced or metastatic 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:
- Co-enrollment to another therapeutic study receiving investigational agent
- Any issue (medical, anatomic, other) that might preclude safe acquisition of
biospecimens at the discretion of the treating physician
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cliff Robinson, M.D.
Phone:
314-362-8567
Email:
clifford.robinson@wustl.edu
Investigator:
Last name:
Cliff Robinson, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Carl DeSelm, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Stephanie Markovina, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Julie Schwarz, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Jessika Contreras, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Dineo Khabele, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
David DeNardo, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Hyun Kim, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Kian-Huat Lim, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Ryan Fields, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Hua Li, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Albert Lai, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Philip Payne, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Doug Caruthers, M.S.
Email:
Sub-Investigator
Investigator:
Last name:
Esther Lu, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Lei Liu, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Andrea Hagemann, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Lindsay Kuroki, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Leslie Stuart Massad, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Carolyn McCourt, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Maggie Mullen, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Matthew Powell, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Brooke Sanders, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Premal Thaker, M.D.
Email:
Sub-Investigator
Start date:
January 11, 2024
Completion date:
December 31, 2032
Lead sponsor:
Agency:
Washington University School of Medicine
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Washington University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05975593
http://www.siteman.wustl.edu
