Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemo-radiotherapy | — | UNRESOLVED | — |
| Gemcitabine | — | UNRESOLVED | — |
| Locally Advanced Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A (Gemcitanine)
- description
- To receive concomitant chemotherapy based on gemcitabine at 300 mg / m2 weekly
- interventionNames
- Drug: Gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- B (Cisplatin)
- description
- To receive concomitant chemotherapy based on cisplatin 40 mg / m2 weekly
- interventionNames
- Drug: Cisplatin
Primary outcomes (1)
- measure
- To assess the efficacy of concomitant chemoradiotherapy with gemcitabine versus cisplatin in patients with locally advanced cervical cancer (stages IB2-IVA), who have comorbidities and preserved renal function, with progression-free survival rate.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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