Comparing Cisplatin and Gemcitabine with Radiotherapy for Cervical 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.

This study is testing whether using Cisplatin or Gemcitabine along with radiation can help people with locally advanced cervical cancer feel better and improve their outcomes.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: National Institute of Cancerología (Government)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Mexico City, Mexico City)
• Trial ID: NCT06156514 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial aims to evaluate the efficacy and safety of concomitant chemo-radiotherapy using either Cisplatin or Gemcitabine as the first line of treatment for patients with locally advanced cervical cancer. The study will enroll 564 patients who will be randomly assigned to receive either Cisplatin or Gemcitabine alongside radiotherapy. The trial will monitor patients over a three-year follow-up period to assess treatment safety and effectiveness, including the evaluation of adverse events and clinical outcomes. The recruitment is planned to occur over four years, with patients receiving treatment in a single hospital center.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 and older with a diagnosis of locally advanced cervical cancer who are eligible for concomitant chemo-radiotherapy.

Not a fit: Patients with advanced comorbidities that preclude them from receiving chemotherapy or radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with locally advanced cervical cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison of Cisplatin and Gemcitabine in this context is novel.

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

Where this trial is running

Mexico City, Mexico City

• National Cancer Institute of Mexico — Mexico City, Mexico City, Mexico (Recruiting)

Study contacts

• Principal investigator: Lucely C Cetina, MSc, PhD — National Cancer Institute of Mexico
• Study coordinator: Lucely C Cetina, MD, MSc

Conditions Locally Advanced Cervical Cancer; Gemcitabine; Chemo-radiotherapy; Locally advanced cervical cancer; Concomitant chemo-radiotherapy; Cisplatin; Comorbidities