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

• Status: Recruiting
• Trial end date: 2029-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Cancerología
• Treatments: Gemcitabine

Criteria

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 GFRthe 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