Locally Advanced Cervical CancerPhase 3MICHELENCT06156514
Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer
A Phase 3 study testing Gemcitabine and Cisplatin in people with Locally Advanced Cervical Cancer and Gemcitabine, run by National Institute of Cancerología at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer, Gemcitabine, Chemo-radiotherapy
- What is being tested?
- Gemcitabine and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteMexico
- Study dates
- 6 Nov 2019to 31 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
National Cancer Institute of Mexico
Mexico City, Mexico City, 14080
Lucely C. Cetina, MD, MSc, +5215531952791, lucelycetina.incan@gmail.com
Julissa Luvián, MSc,PhD, +5215569347316, juli.luvian.morales@gmail.com
About this study
Official title: 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.
Read the detailed description
This is a phase III clinical trial, open, randomized 1: 1, controlled, noninferiority, in a single hospital center. This study will include 564 patients with the diagnosis of malignant tumors of epithelial origin of the cervix.
Patients will be randomized 1: 1, arm "A" (experimental) to receive concomitant chemotherapy based on gemcitabine at 300 mg / m2 weekly and Arm "B" (control) to receive cisplatin 40 mg / m2 weekly, both arms with RT 50.4 Gy in 5 weeks plus 30Gy brachytherapy at the end of the concomitance. These patients will be treated in the gynecology-oncology service, candidates for chemo-radiotherapy, it is intended that the recruitment of patients be done in the first 48 months, with a follow-up of 3 years. It is intended to include 3 patients per month, until the total sample is completed in four years. The study is divided into three phases, the first of QT / RT concomitant with gemcitabine or cisplatin depending on the randomized arm; with an approximate duration of 1.5 months with a weekly visit, the second phase is brachytherapy in both arms which lasts from 2 to 7 days, and finally the follow-up phase which lasts for 3 years with a visit every 3 months. In each of the visits we will evaluate the safety of the medication; evaluating adverse events, including laboratory abnormalities as well as acute and chronic toxicity, with the classification according to the common toxicity criteria (CTCAE v4.03) and the efficacy will obtain proportions of clinical and imaging response (TC and / or PET-CT) with the criteria of RECIST v1.1 and / or PERCIST 1.0.
Patient numbers to include. This study will include 140 patients. Test drug, dosage, mode of administration: Gemcitabine at 300 mg / m2 weekly intravenous administration.
Duration of the study 9 years.
- Being tested
- Gemcitabine, Cisplatin
- Keywords
- Locally advanced cervical cancer (LACC), Concomitant chemo-radiotherapy, Gemcitabine, Cisplatin, Comorbidities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
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
CisplatinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| A (Gemcitanine) | Experimental | To receive concomitant chemotherapy based on gemcitabine at 300 mg / m2 weekly Receives: Drug: Gemcitabine |
| B (Cisplatin) | Active comparator | To receive concomitant chemotherapy based on cisplatin 40 mg / m2 weekly Receives: Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Objective response rate:
Percentage of people in a study or treatment group who have a partial or complete response to treatment in a given period of time.
The measurement is evaluated with RECIST v1.1 or PERCIST criteria
Measured: 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.
This incidence of Treatment-Emergent Adverse Events will be evaluated through the toxicity profile of the treatment, the evaluation will be classified with the CTCAE v 4.3 criteria.
Measured: 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.
Percentage of people in a study or treatment group who have a partial or complete response to treatment in a given period of time.
The measurement is evaluated with RECIST v1.1 or PERCIST criteria
- Complete response as the absence of medible disease.
- Partial response as the reduction of al least 30% of the size of the tumor (medible disease).
Measured: 1 year
Document the prevalence of comorbidities in this group of patients
Point prevalence: refers to the number of cases of a health event at a given time. This is the case to evaluate the presence of comorbidities in patients with cervical cancer at the time of diagnosis of the oncological disease
Measured: 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.
The quality of life to be evaluated with a given score from 0 to 100, based on the answers of the EORTC QLQ-30 y QLQ Cx-24 questionnaires (patient answer in a 0-4 scale) to the patients at the beginning of treatment, at the fourth week of treatment, during brachytherapy and every three months during the first year of follow up. For symptom scales a high score is indicative of greater problems and for functional scales a low score is indicative of greater problems.
Measured: 1.5 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 CX-24 questionnaires.
The quality of life to be evaluated with a given score from 0 to 100, based on the answers of the EORTC QLQ-30 y QLQ Cx-24 questionnaires (patient answer in a 0-4 scale) to the patients at the beginning of treatment, at the fourth week of treatment, during brachytherapy and every three months during the first year of follow up. For symptom scales a high score is indicative of greater problems and for functional scales a low score is indicative of greater problems.
Measured: 1.5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start6 Nov 2019
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cancerología
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lucely Cetina Pérez, National Institute of Cancerología
- Investigators
- Eder A Arango, MD, Study director, National Cancer Institute of MexicoLucely C Cetina, MSc, PhD, Principal investigator, National Cancer Institute of Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156514
- Sponsor's protocol ID
- (018/066/ICI) (CEI/1308/18).
- Acronym
- MICHELE
- Status last verified
- May 2025
- First submitted
- 28 Jun 2023
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06156514
- Acronym / sponsor ID
- MICHELE / (018/066/ICI) (CEI/1308/18).
- Keywords
- Locally advanced cervical cancer (LACC), Concomitant chemo-radiotherapy, Gemcitabine, Cisplatin, Comorbidities
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- National Institute of CancerologíaOther government
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase III clinical trial, open, randomized 1: 1, controlled, noninferiority, in a single hospital center. This study will include 564 patients with the diagnosis of malignant tumors of epithelial origin of the cervix.
Patients will be randomized 1: 1, arm "A" (experimental) to receive concomitant chemotherapy based on gemcitabine at 300 mg / m2 weekly and Arm "B" (control) to receive cisplatin 40 mg / m2 weekly, both arms with RT 50.4 Gy in 5 weeks plus 30Gy brachytherapy at the end of the concomitance. These patients will be treated in the gynecology-oncology service, candidates for chemo-radiotherapy, it is intended that the recruitment of patients be done in the first 48 months, with a follow-up of 3 years. It is intended to include 3 patients per month, until the total sample is completed in four years. The study is divided into three phases, the first of QT / RT concomitant with gemcitabine or cisplatin depending on the randomized arm; with an approximate duration of 1.5 months with a weekly visit, the second phase is brachytherapy in both arms which lasts from 2 to 7 days, and finally the follow-up phase which lasts for 3 years with a visit every 3 months. In each of the visits we will evaluate the safety of the medication; evaluating adverse events, including laboratory abnormalities as well as acute and chronic toxicity, with the classification according to the common toxicity criteria (CTCAE v4.03) and the efficacy will obtain proportions of clinical and imaging response (TC and / or PET-CT) with the criteria of RECIST v1.1 and / or PERCIST 1.0.
Patient numbers to include. This study will include 140 patients. Test drug, dosage, mode of administration: Gemcitabine at 300 mg / m2 weekly intravenous administration.
Duration of the study 9 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| A (Gemcitanine) | Experimental | Drug: GemcitabineTo receive concomitant chemotherapy based on gemcitabine at 300 mg / m2 weekly |
| B (Cisplatin) | Active comparator | Drug: CisplatinTo receive concomitant chemotherapy based on cisplatin 40 mg / m2 weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Singed informed consent.
- Women with Age ≥ 18 years.
- 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.
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcitabineWeekly 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 | Drug | A (Gemcitanine) |
| CisplatinWeekly 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 | Drug | B (Cisplatin) |
Primary outcome
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.
Time frame: 3 year
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.
6 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Document the prevalence of comorbidities in this group of patients
Time frame: 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.
Time frame: 1.5 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 CX-24 questionnaires.
Time frame: 1.5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eder A Arango, MD study director
National Cancer Institute of Mexico
Lucely C Cetina, MSc, PhD principal investigator
National Cancer Institute of Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gemcitabine and Cisplatin in people with Locally Advanced Cervical Cancer and Gemcitabine, run by National Institute of Cancerología at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucely C Cetina, MD, MSc (+5215531952791, lucelycetina.incan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.