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Compares treatment options for Locally Advanced Cervical Cancer
Official title Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer
ClinicalTrials.gov ID: NCT06156514
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for locally advanced cervical cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- -In postmenopausal women (surgical or natural menopause) at least one of the following parameters must be met for inclusion.
- Previous bilateral oophorectomy
You likely can't join 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
See the full eligibility criteria
- 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...
- -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).
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Mexico City, Mexico
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Mexico City, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.