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

Recruiting now · Phase 3

Conditions studied: Locally Advanced Cervical Cancer, Gemcitabine, Chemo-radiotherapy

In brief

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.

Key facts

Study ID: NCT06156514
Run by: National Institute of Cancerología
People needed: 140
Starts: 2019-11-06
Expected to finish: 2029-12-31
Last updated by the study team: 2025-05-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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

Where it is running

National Cancer Institute of Mexico — Mexico City, Mexico City, Mexico (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.