Uterine Cervix Cancer
Conditions
Brief summary
This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix cancer. Women receive standard-of-care radiochemotherapy followed by brachytherapy. Blood samples are obtained to detect circulating levels of deoxyribonucleotides, human papillomavirus DNA, and circulating tumor cells.
Interventions
RADIATIONStandard
Radiation then brachytherapy
Sponsors
Denise Fabian
UK Radiopharma Alliance
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Untreated pathologically or cytologically-confirmed diagnosis of stage IB3 (\> 4cm), II, III, or IVA (FIGO 2018) squamous, adenosquamous, or adenocarcinoma of the uterine cervix not amenable to curative surgery alone.
Exclusion criteria
* Presence of another concurrent active invasive malignancy * Prior invasive malignancy diagnosed within the last three years except for \[1\] non-melanoma skin cancer or \[2\] prior in situ carcinoma of the cervix * prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker | 3 months posttherapy | deoxyribonucleotide levels |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDenise Fabian, MD
University of Kentucky
Outcome results
None listed