MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer (MILES-3)

March 23, 2023 updated by: National Cancer Institute, Naples

Randomized Phase III Study of the Addition of Cisplatin in Combination With Gemcitabine as First-line Therapy for Elderly Patients With Advanced Non Small Cell Lung Cancer.

The purpose of this study is to evaluate the addition of cisplatin to first-line chemotherapy with gemcitabine in elderly patients with non small cell lung cancer in terms of overall survival.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
299

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alba, Italy
        • Ospedale San Lazzaro
      • Albano Laziale, Italy
        • Ospedale Regina Apostolorum
      • Ancona, Italy
        • AOU Ospedale Riuniti Umberto I
      • Aprilia, Italy
        • ASL Latina Distretto 1 Aprilia Univ.degli Studi di Roma
      • Asti, Italy
        • Ospedale Cardinale Massaia
      • Avellino, Italy
        • S. Giuseppe Moscati
      • Aviano, Italy
        • Centro Riferimento Oncologico
      • Brindisi, Italy
        • Ospedale Senatore Antonio Perrino
      • Campobasso, Italy
        • Ospedale A. Cardarelli
      • Carpi, Italy
        • Ospedale Ramazzini di Carpi
      • Casale Monferrato, Italy
        • Ospedale S. Spirito
      • Catania, Italy
        • A.O. Garibaldi Nesima
      • Catanzaro, Italy
        • Ospedale Mater Domini
      • Chioggia, Italy
        • Ospedale della Madonna della Navicella
      • Faenza, Italy
        • Ospedale Civile di Faenza
      • Ferrara, Italy
        • A.O.U. Arcispedale Sant'Anna di Ferrara
      • Gaeta, Italy
        • Ospedale Don Luigi Di Liegro
      • Genova, Italy
        • IRCCS San Martino -IST Genova
      • Isernia, Italy
        • Ospedale F. Veneziale
      • Lecce, Italy
        • A.O. Vito Fazzi-Lorusso
      • Legnano, Italy
        • Ospedale Civile di Legnano
      • Meldola, Italy
        • Istituto Sceintifico Romagnolo
      • Milano, Italy
        • Ospedale San Paolo
      • Milano, Italy
        • Ospedale L. Sacco Polo Universitario
      • Mirano, Italy
        • U.L.S.S. 13
      • Monza, Italy
        • Ospedale San Gerardo
      • Napoli, Italy
        • Istituto Nazionale Dei Tumori
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Cardarelli
      • Napoli, Italy, 80131
        • Second University of Naples
      • Napoli, Italy
        • A.O. Università Federico II
      • Napoli, Italy
        • AORN Ospedale dei Colli - Osp Monaldi
      • Padova, Italy
        • Istituto Oncologico Veneto
      • Pagani, Italy
        • Ospedale Andrea Tortora Pagani - Ospedale Civile Umbero I
      • Palermo, Italy
        • Casa di Cura La Maddalena
      • Palermo, Italy
        • Ospedale Buccheri La Ferla - Fatebenefratelli
      • Pavia, Italy
        • Fondazione Salvatore Maugeri
      • Piacenza, Italy
        • Ospedale Guglielmo d Saliceto-Piacenza
      • Potenza, Italy
        • Azienda Ospedaliera S. Carlo
      • Ravenna, Italy
        • Ospedale S. Maria delle Croci
      • Ravenna, Italy
        • Ospedale Umberto I
      • Roma, Italy
        • Ospedale S. Giovanni Calibita Fatebenefratelli
      • Roma, Italy
        • A.O. S. Camillo Forlanini
      • Roma, Italy
        • Campus Biomedico Policlinio Universitario
      • Vercelli, Italy
        • Ospedale S. Andrea
      • Vicenza, Italy
        • Ospedale S. Bortolo ULSS 6
      • Viterbo, Italy
        • ASL Viterbo - Ospedale Belcolle
    • GE
      • Genova, GE, Italy, 16100
        • Ospedale Villa Scassi
    • PA
      • Palermo, PA, Italy, 90127
        • Policlinico Giaccone
    • SI
      • Siena, SI, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cytological or histological diagnosis of non small-cell lung cancer (NSCLC)
  • Stage III B or Stage IV disease
  • Age > or = 70 years
  • ECOG Performance status 0 or 1
  • Patient at first diagnosis or with recurrence after primary surgery
  • At least one target or non-target lesion according to RECIST criteria
  • Life expectancy of at least 3 months
  • Neutrophils > 1500/mm3, platelets > 100,000/mm3, hemoglobin > 10g/dl
  • Creatinine < 1.5 x the upper normal limit
  • AST and ALT < 2.5 x the upper normal limits (< 5 x the upper normal limit in the presence of hepatic metastasis)
  • Bilirubin < 1.5 x the upper normal limit
  • Signed informed consent

Exclusion Criteria:

  • Previous chemotherapy for advanced disease
  • History of malignant neoplasm within the previous 5 years (not including non-melanoma skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
  • Symptomatic cerebral or spinal cord metastasis
  • Myocardial infarct within the last 12 months
  • Systemic disease not controlled with treatment (active infection, cardiovascular, hepatic, renal or metabolic) that would not, in the opinion of the investigator, permit the patient to undergo chemotherapy.
  • Known or suspected hypersensitivity to any of the drugs used in the study
  • Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: gemcitabine
Drug: Gemcitabine
1000mg/m2 days 1 and 8 every 3 weeks for 6 cycles
Drug: Gemcitabine
1200 mg/m2 days 1 and 8 every 3 weeks for 6 cycles
Experimental: gemcitabine + cisplatin
Drug: Gemcitabine
1000mg/m2 days 1 and 8 every 3 weeks for 6 cycles
Drug: Gemcitabine
1200 mg/m2 days 1 and 8 every 3 weeks for 6 cycles
Drug: Cisplatin
60 mg/m2 day 1 every 3 weeks for 6 cycles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
overall survival
Time Frame: one year
one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
worst grade toxicity per patient
Time Frame: at end of each 3 week cycle of chemotherapy
worst toxicity per patient according to Common Toxicitity Criteria for Adverse Events v. 4.03
at end of each 3 week cycle of chemotherapy
progression free survival
Time Frame: every 9 weeks
every 9 weeks
quality of life
Time Frame: baseline and 8, 21, 29, and 42 days after therapy initiated
baseline and 8, 21, 29, and 42 days after therapy initiated
objective response
Time Frame: after 9 and 18 weeks of therapy
after 9 and 18 weeks of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Institute, Naples

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MILES-3
  • 2009-013540-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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