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

Summary

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.

Eligibility

Inclusion Criteria:

* Singed informed consent.
* Women with Age ≥ 18 years.

  1. -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.
  2. -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:

  1. Hb equal to or greater than 10g /l. (Transfusion prior to treatment is allowed to reach this level of hemoglobin).
  2. Leukocytes greater than or equal to 4000 / mm3.
  3. Platelets equal to or greater than 100,000mm3.
  4. 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).

Exclusion Criteria:

* Patients with a second neoplasm.
* Pregnant or lactating patients.
* Patients with small cell and / or neuroendocrine CaCu.
* Patients with impaired renal function with a GFR \<or equal to 60ml / min calculated by the CKD-EPI formula
* Patients with a history of active TB (TB)
* Patients with a history of Human Immunodeficiency Virus (HIV) infection
* Patients with vesico-vaginal or vesicorectal fistulas at diagnosis
* 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:

* Evidence of disease progression.
* If treating physician considers that a change of therapy may benefit the patient.
* 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

Conditions4

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