Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer
Not Applicable
Recruiting
- Conditions
- Uterine Cervix Cancer
- Interventions
- Radiation: Standard
- Registration Number
- NCT05462951
- Lead Sponsor
- Denise Fabian
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiochemotherapy followed by brachytherapy Standard Standard daily radiotherapy plus weekly cisplatin followed by brachytherapy
- Primary Outcome Measures
Name Time Method Biomarker 3 months posttherapy Circulating tumor cell count
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Markey Cancer Center
🇺🇸Lexington, Kentucky, United States