Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer

Korábbi kezelés

• Concomitant treatment with another experimental drug. Social, family or geographical conditions that suggest a poor attachment to the study
  • Criteria Interruption of Treatment (Withdrawal of patients)
  • A patient will be discontinued from the study under the following circumstances:
• If treating physician considers that a change of therapy may benefit the patient.

Más betegség

• Patients with a history of active TB (TB)
• Patients with a history of Human Immunodeficiency Virus (HIV) infection
• Evidence of disease progression.

Laborértékek

• Patients with impaired renal function with a GFR <or equal to 60ml / min calculated by the CKD-EPI formula

Egyéb

• Patients with a second neoplasm.
• Pregnant or lactating patients.
• Patients with small cell and / or neuroendocrine CaCu.
• Patients with vesico-vaginal or vesicorectal fistulas at diagnosis
• If patient withdrew consent
• Due to unmanageable toxicity By pregnancy or if the patient does not wish to continue using the contraceptive methods indicated by the attending physician

• 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).