Compares two drugs given with radiation for locally advanced cervical cancer
Tests gemcitabine versus cisplatin with radiotherapy in adults with cervical cancer and other health conditions.
Plain-language title generated from the registry record
Registry title: Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer
Key facts
- Where
- Mexico City, MexicoSee the site
- Phase
- Phase 3
Where in Mexico
- National Cancer Institute of MexicoMexico City, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Institute of Cancerología
- Trial code
- NCT06156514
- Record updated
- 28 May 2025
- Original description
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.Read full original descriptionShow less
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.
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.
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: 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:; If treating physician considers that a change of therapy may benefit the patient; Patients with a history of active TB (TB); Patients with a history of Human Immunodeficiency Virus (HIV) infection; Evidence of disease progression; Patients with impaired renal function with a GFR <or equal to 60ml / min calculated by the CKD-EPI formula; Patients with a second neoplasm; Pregnant or lactating patients; Patients with small cell and / or neuroendocrine CaCu; Patients with vesico-vaginal or vesicorectal fistulas at diagnosis; 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.