MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tumor collection via biopsy, Blood collection, Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI).
- Who it may be relevant to
- Registry conditions: Locally Advanced Cervical Carcinoma, Locally Advanced Cervical Cancer, Locally Advanced Pancreas Cancer, Locally Advanced Pancreatic Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial (METEOR-CRATR)
Overview
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.
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.
Primary outcome measures
- Changes in tumor microenvironment [Time frame: From start of follow-up through completion of follow-up (estimated to be 5 years)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT05975593 · 202307103 · U54CA274318