Status:
RECRUITING
Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer
Lead Sponsor:
National Institute of Cancerología
Conditions:
Locally Advanced Cervical Cancer
Gemcitabine
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 loc...
Detailed Description
This is a phase III clinical trial, open, randomized 1: 1, controlled, noninferiority, in a single hospital center. This study will include 564 patients with the diagnosis of malignant tumors of epith...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
November 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06156514
Start Date
November 6 2019
End Date
December 31 2029
Last Update
May 28 2025
Active Locations (1)
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1
National Cancer Institute of Mexico
Mexico City, Mexico City, Mexico, 14080