Status:
UNKNOWN
How To Evaluate The Efficiency And Safety Of Neoadjuvant Chemotherapy In Locally Advanced Cancer Cervix
Lead Sponsor:
Assiut University
Conditions:
Locally Advanced Cervical Carcinoma
Eligibility:
FEMALE
20-75 years
Phase:
PHASE2
Brief Summary
1. This strategy might suggest a therapeutic option to preserve ovarian function in young patients among which locally advanced cancer cervix is common. Based on previous studies, neoadjuvant irinotec...
Detailed Description
Treatments for locally advanced cervical cancer, defined as International Federation of Gynecology and Obstetrics (FIGO) stage Ib2-III include primary surgery, neoadjuvant chemotherapy and concurrent ...
Eligibility Criteria
Inclusion
- 1 - Patients with histologically confirmed invasive squamous cell carcinoma of the uterine cervix; (ii) FIGO stage system (2018 version): stage II-III 2- No previous treatment. 3- patients with age of 20-75 years at enrollment. 4- Eastern Cooperative Oncology Group performance status (PS) of 0 or 1. 5- Preserved function of major organs (bone marrow, heart, liver and kidney) 6- Lab values within specified ranges, including a neutrophil count greater than 2000/μL, a platelet count greater than 100 000/ mm3 , a hemoglobin level greater than 9.0 g/dL (values after blood transfusion are accepted), levels of aspartate aminotransferase and alanine aminotransferase less than 100 IU/L, a total bilirubin level less than 1.5 mg/dL, a serum creatinine level less than 1.5 mg/dL, creatinine clearance greater than 60 mL/ min.
Exclusion
- :
- Distinct evidence of infectious disease.
- Serious concurrent disease (cardiac disease, uncontrolled diabetes mellitus, malignant hypertension and a bleeding tendency).
- Pregnant women, or women who want to become pregnant.
- History of serious drug hypersensitivity or drug allergy.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04789941
Start Date
April 1 2021
End Date
December 30 2021
Last Update
March 10 2021
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