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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

Evaluation 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, is a Phase III Clinical Trial.

Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer (NCT06156514) is a Phase 3 interventional studying Locally Advanced Cervical Cancer and Gemcitabine, sponsored by National Institute of Cancerología. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Locally Advanced Cervical Cancer, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 140 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Locally Advanced Cervical Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Singed willing to sign a consent form. - 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. - kidney function (creatinine clearance) at least 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Gemcitabine

Weekly application of gemcitanibe at 300 mg/m2 intravenously in a 30-minute infusion, concomitantly with radiotherapy for a total of 5-6 weeks followed by bachytherapy, in patients diagnosed with locally advanced cervical cancer

DRUG

Cisplatin

Weekly application of Cisplatin at 40 mg/m2 intravenously in a 60-minute infusion, concomitantly with radiotherapy for a total of 5-6 weeks followed by bachytherapy, in patients diagnosed with locally advanced cervical cancer

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

National Cancer Institute of Mexico
Mexico City, Mexico City, Mexico

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06156514), the sponsor (National Institute of Cancerología), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06156514 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06156514?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06156514?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06156514. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06156514. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.