Status:
UNKNOWN
Identification of a MOLecuLar Signature in Locally Advanced Cervical Cancer Patients
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Cervical Cancer
Eligibility:
FEMALE
19+ years
Brief Summary
The importance of radioresistance in cervical cancer treatment failure indicates that certain biomarkers may be useful for cervical cancer treatment individualization. However, to date, no study has a...
Detailed Description
The importance of radioresistance in cervical cancer treatment failure indicates that certain biomarkers may be useful for cervical cancer treatment individualization. Several biomarkers of cervical c...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- FIGO 2018 stage IIB and IIIC1\[38\]
- Treatment with exclusive chemoradiation including brachytherapy
- Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer
- Has radiographically evaluable disease, measurable per RECIST 1.1
- Negative pregnancy test
- Adequate hematologic, renal, and hepatic functions, with following blood tests:
- Neutrophils \> 1500/μL Platelets \> 100.000/ μL Hemoglobin \> 9 g/dL Serum creatinine \< 1.8 mg/dL Total bilirubin \< 3 mg/ dL LDH \< 3x normal value GOT \< 3x normal value GPT \< 3x normal value ALP \< 3 x normal value
Exclusion
- Rare cervical cancer histologies (neuroendocrine, glassy cells, serous, endometrioid etc)
- Neo-adjuvant treatment
- Patients included in other clinical trials
- Patients refusing to sign informed consent
- Contraindications to radiotherapy
- Contraindications to pelvic radiotherapy: ulcerative colitis, diverticulitis, chronic pelvic inflammatory disease, previous pelvic radiotherapy
Key Trial Info
Start Date :
August 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06016868
Start Date
August 1 2023
End Date
August 1 2025
Last Update
August 30 2023
Active Locations (1)
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1
Policlinico Universitario Agostino Gemelli, IRCCS
Rome, Italy