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MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

ConditionsLocally Advanced Cervical CarcinomaLocally Advanced Cervical CancerLocally Advanced Pancreas CancerLocally Advanced Pancreatic CarcinomaLocally Advanced Pancreatic CancerCervical CancerPancreas CancerPancreatic CancerCancer of the CervixCancer of the Pancreas
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cervical cancer

Pancreatic cancer

ECOG performance status ≤ 2

At least 18 years old

Disqualifiers

Any issue (medical, anatomic, other) that might preclude safe acquisition of biospecimens at the discretion of the treating physician

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tumor collection via biopsy

    Other intervention

    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

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Cervical CancerOther 3 interventions
Group B: Pancreatic CancerOther 3 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

National Cancer Institute (NCI)

Collaborator

The Foundation for Barnes-Jewish Hospital

Collaborator

Source ClinicalTrials.gov
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