NCT06156514 Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer
| NCT ID | NCT06156514 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | National Institute of Cancerología |
| Condition | Locally Advanced Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2019-11-06 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 140 participants in total. It began in 2019-11-06 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 locally advanced cervical cancer, with comorbidities and preserved renal function.
Eligibility 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 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
Contact & Investigator
Eder A Arango, MD
STUDY DIRECTOR
National Cancer Institute of Mexico
Frequently Asked Questions
Who can join the NCT06156514 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Locally Advanced Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06156514 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 140 participants.
Is NCT06156514 currently recruiting?
Yes, NCT06156514 is actively recruiting participants. Contact the research team at lucelycetina.incan@gmail.com for enrollment information.
Where is the NCT06156514 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT06156514 clinical trial?
NCT06156514 is sponsored by National Institute of Cancerología. The principal investigator is Eder A Arango, MD at National Cancer Institute of Mexico. The trial plans to enroll 140 participants.
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