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

NCT06156514 | Recruiting Phase 3

• 1 other identifier: (018/066/ICI) (CEI/1308/18).
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Locally Advanced Cervical Cancer; Gemcitabine; Chemo-radiotherapy

Keywords

Locally advanced cervical cancer (LACC); Concomitant chemo-radiotherapy; Gemcitabine; Cisplatin; Comorbidities

Outcome Measures

Primary Outcomes (1)

• 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.

  Efficacy will be estimated with progression-free survival: this is defined as the period from the randomization to the first progression documented by imaging studies by RECIST criteria.

  3 year

Secondary Outcomes (6)

• To determine the objective response rate after the treatment of concomitant QT-RT with Gemcitabine vs cisplatin in patients with locally advanced cervical cancer with stages IB2-IVA, with comorbidities and preserved renal function.

  8 weeks at the end of treatment

• Incidence of Treatment-Emergent Adverse Events of concomitant QT-RT with gemcitabine vs cisplatin in patients with locally advanced cervical cancer with stages IB2-IVA with comorbidities and preserved renal function.

  1 year

• Determine the Overall Response Rate (ORR) defined as the percentage of people in the study with partial or complete response to treatment in a given period of time, assessed by RECIST v1.1 and PERCIST criteria.

  1 year

• Document the prevalence of comorbidities in this group of patients

  Through the study completion, an average of 6 years.

• To evaluate the quality of life of patients with locally advanced cervical cancer with stages IB2-IVA, with comorbidities and preserved renal function with the EORTC QLQ-30.

  1.5 years.

Study Arms (2)

A (Gemcitanine)

EXPERIMENTAL

To receive concomitant chemotherapy based on gemcitabine at 300 mg / m2 weekly

Drug: Gemcitabine

B (Cisplatin)

ACTIVE COMPARATOR

To receive concomitant chemotherapy based on cisplatin 40 mg / m2 weekly

Drug: Cisplatin

Interventions

Gemcitabine DRUG

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

A (Gemcitanine)

Cisplatin DRUG

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

B (Cisplatin)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: In the inclusion are patients with the diagnosis confirmed by pathology of cervical-uterine cancer (an exclusive organ of the female gender).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.
• 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.

You may not qualify 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
• 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

Sponsors & Collaborators

• National Institute of Cancerología: lead

Study Sites (1)

National Cancer Institute of Mexico

Mexico City, Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Interventions

Gemcitabine; Cisplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Eder A Arango, MD

  National Cancer Institute of Mexico

  STUDY DIRECTOR

• Lucely C Cetina, MSc, PhD

  National Cancer Institute of Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucely C Cetina, MD, MSc

CONTACT

+5215531952791; lucelycetina.incan@gmail.com

Julissa Luvián, MSc, PhD

CONTACT

+521556934; juli.luvian.morales@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: This is a phase III clinical trial, open, randomized 1: 1, controlled, noninferiority, in a single hospital center. This study will include 140 patients with the diagnosis of malignant tumors of epithelial origin of the cervix. Patients will be randomized 1: 1 to receive in arm "A" (experimental) to receive concomitant chemotherapy based on gemcitabine at 300 mg / m2 weekly and Arm "B" (control) cisplatin 40 mg / m2 weekly, both arms with RT 50.4 Gy in 5 weeks plus 30Gy brachytherapy at the end of the concomitance.

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: December 5, 2023
• Study Start: November 6, 2019
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)