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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

299

Phase

  • 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

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
Intervention / Treatment
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

Outcome Measure
Time Frame
overall survival
Time Frame: one year
one year

Secondary Outcome Measures

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

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)

March 1, 2011

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

July 28, 2011

First Posted (Estimate)

July 29, 2011

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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