Evaluation of Concomitant Chemo-radiotherapy With Cisplatin vs Gemcitabine as the First Line of Treatment in Patients With Locally Advanced Cervical Cancer, With Comorbidities and Preserved Renal Function, is a Phase III Clinical Trial.
The purpose of this phase III clinical trial, is to evaluate the efficacy and safety of concomitant chemo-radiotherapy with Cisplatin vs Gemcitabine as the first line of treatment in patients with locally advanced cervical cancer, with comorbidities and preserved renal function.
• Singed informed consent.
• Women with Age ≥ 18 years.
∙ -In women of childbearing age it should be documented: a) negative pregnancy test in serum at the beginning of the study (14 days before the start of QT-RT); b) Accept the use of some method of contraception approved by your attending physician during the study and 12 weeks after the treatment has ended.
‣ -In postmenopausal women (surgical or natural menopause) at least one of the following parameters must be met for inclusion.
• Previous bilateral oophorectomy
• Age ≥ 60 years
• Age \<60 years and amenorrhea for at least 12 months and levels of follicle stimulating hormone and estradiol within postmenopausal interval parameters.
• Diagnosis of CaCu EC IB2 mg/dl With histological confirmation (epidermoid, adenocarcinoma or adenoescamoso).
• Patients who are candidates for treatment with concomitant QT / RT.
• ECOG 0-2.
• Measurable disease by CT scan and magnetic resonance imaging of the pelvis according to the RECIST criteria v1.1
• No previous treatment.
• Creatinine clearance ≥ 60 ml / min calculated by the CKD-EPI formula.
• Patients with adequate hematological and hepatic functioning, defined by the following parameters:
∙ Hb equal to or greater than 10g /l. (Transfusion prior to treatment is allowed to reach this level of hemoglobin).
‣ Leukocytes greater than or equal to 4000 / mm3.
‣ Platelets equal to or greater than 100,000mm3.
‣ Total bilirubin ≤1.5 times the upper limit of normal (ULN) and. Transaminases less than 1.5 times the LSN
• Patients with a prior diagnosis of the following comorbidities:
‣ Diabetes mellitus type 2, which has: fasting serum glucose \<250 mg/dl.
⁃ Systemic arterial hypertension G1 or G2 according to CTCAE v4.03
⁃ Child Pugh A liver disease
⁃ Cardiovascular diseases such as: Ischemic heart disease undergoing asymptomatic treatment, without clinical data of stable or unstable angina or for acute myocardial infarction.
⁃ Compensated heart failure in functional class I of the New York Heart Association.
⁃ Systemic Lupus Erythematosus with mild or inactive lupus activity (less than or equal to 4 points according to the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI).