Recruiting

Chemoradiotherapy

Sponsor:

Washington University School of Medicine

Code:

NCT05975593

Conditions

Locally Advanced Cervical Carcinoma

Locally Advanced Cervical Cancer

Locally Advanced Pancreas Cancer

Locally Advanced Pancreatic Carcinoma

Locally Advanced Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tumor collection via biopsy

Blood collection

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

Study Details

Brief 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

Study ID

NCT05975593

Start date

Jan 11, 2024

Status verified date

Aug, 2026

Completion date

Dec 31, 2032

Anticipated

Primary completion date

Dec 31, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: 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.

other: 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.

Interventions

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.

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

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.

Primary outcome measure

  • Changes in tumor microenvironment [ Time Frame: From start of follow-up through completion of follow-up (estimated to be 5 years) ]

Central Contacts and Locations

Central contacts

Michael Waters, M.D., Ph.D.

314-273-0275m.r.waters@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Michael Waters, M.D., Ph.D.

314-273-0275m.r.waters@wustl.edu

Principal Investigator:

Michael Waters, M.D., Ph.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Radiotherapy
  • Chemotherapy
  • Cervical cancer
  • Pancreatic cancer
  • Biospecimen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-08-17.