search
Back to results

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

Primary Purpose

Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage IIIB

Status
Active
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Gemcitabine
Gemcitabine
Cisplatin
Sponsored by
National Cancer Institute, Naples
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer Metastatic focused on measuring elderly, chemotherapy

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Villa Scassi
  • Policlinico Giaccone
  • Azienda Ospedaliera Universitaria Senese
  • Ospedale Regina Apostolorum
  • Ospedale San Lazzaro
  • AOU Ospedale Riuniti Umberto I
  • ASL Latina Distretto 1 Aprilia Univ.degli Studi di Roma
  • Ospedale Cardinale Massaia
  • S. Giuseppe Moscati
  • Centro Riferimento Oncologico
  • Ospedale Senatore Antonio Perrino
  • Ospedale A. Cardarelli
  • Ospedale Ramazzini di Carpi
  • Ospedale S. Spirito
  • A.O. Garibaldi Nesima
  • Ospedale Mater Domini
  • Ospedale della Madonna della Navicella
  • Ospedale Civile di Faenza
  • A.O.U. Arcispedale Sant'Anna di Ferrara
  • Ospedale Don Luigi Di Liegro
  • IRCCS San Martino -IST Genova
  • Ospedale F. Veneziale
  • A.O. Vito Fazzi-Lorusso
  • Ospedale Civile di Legnano
  • Istituto Sceintifico Romagnolo
  • Ospedale L. Sacco Polo Universitario
  • Ospedale San Paolo
  • U.L.S.S. 13
  • Ospedale San Gerardo
  • Azienda Ospedaliera Cardarelli
  • Second University of Naples
  • A.O. Università Federico II
  • AORN Ospedale dei Colli - Osp Monaldi
  • Istituto Nazionale dei Tumori
  • Istituto Oncologico Veneto
  • Ospedale Andrea Tortora Pagani - Ospedale Civile Umbero I
  • Casa di Cura La Maddalena
  • Ospedale Buccheri La Ferla - Fatebenefratelli
  • Fondazione Salvatore Maugeri
  • Ospedale Guglielmo d Saliceto-Piacenza
  • Azienda Ospedaliera S. Carlo
  • Ospedale S. Maria delle Croci
  • Ospedale Umberto I
  • A.O. S. Camillo Forlanini
  • Campus Biomedico Policlinio Universitario
  • Ospedale S. Giovanni Calibita Fatebenefratelli
  • Ospedale S. Andrea
  • Ospedale S. Bortolo ULSS 6
  • ASL Viterbo - Ospedale Belcolle

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

gemcitabine

gemcitabine + cisplatin

Arm Description

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

worst grade toxicity per patient
worst toxicity per patient according to Common Toxicitity Criteria for Adverse Events v. 4.03
progression free survival
quality of life
objective response

Full Information

First Posted
February 26, 2010
Last Updated
March 23, 2023
Sponsor
National Cancer Institute, Naples
search

1. Study Identification

Unique Protocol Identification Number
NCT01405586
Brief Title
MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer
Acronym
MILES-3
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2011 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Naples

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage IIIB
Keywords
elderly, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
299 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gemcitabine
Arm Type
Active Comparator
Arm Title
gemcitabine + cisplatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
1000mg/m2 days 1 and 8 every 3 weeks for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
1200 mg/m2 days 1 and 8 every 3 weeks for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
60 mg/m2 day 1 every 3 weeks for 6 cycles
Primary Outcome Measure Information:
Title
overall survival
Time Frame
one year
Secondary Outcome Measure Information:
Title
worst grade toxicity per patient
Description
worst toxicity per patient according to Common Toxicitity Criteria for Adverse Events v. 4.03
Time Frame
at end of each 3 week cycle of chemotherapy
Title
progression free survival
Time Frame
every 9 weeks
Title
quality of life
Time Frame
baseline and 8, 21, 29, and 42 days after therapy initiated
Title
objective response
Time Frame
after 9 and 18 weeks of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesare Gridelli, M.D.
Organizational Affiliation
S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Perrone, M.D., Ph.D
Organizational Affiliation
National Cancer Institute Naples, Italy; Director Clinical Trials Unit
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ciro Gallo, M.D., Ph.D
Organizational Affiliation
Second University of Naples, Italy; Chair of Medical Statistics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Villa Scassi
City
Genova
State/Province
GE
ZIP/Postal Code
16100
Country
Italy
Facility Name
Policlinico Giaccone
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese
City
Siena
State/Province
SI
ZIP/Postal Code
53100
Country
Italy
Facility Name
Ospedale Regina Apostolorum
City
Albano Laziale
Country
Italy
Facility Name
Ospedale San Lazzaro
City
Alba
Country
Italy
Facility Name
AOU Ospedale Riuniti Umberto I
City
Ancona
Country
Italy
Facility Name
ASL Latina Distretto 1 Aprilia Univ.degli Studi di Roma
City
Aprilia
Country
Italy
Facility Name
Ospedale Cardinale Massaia
City
Asti
Country
Italy
Facility Name
S. Giuseppe Moscati
City
Avellino
Country
Italy
Facility Name
Centro Riferimento Oncologico
City
Aviano
Country
Italy
Facility Name
Ospedale Senatore Antonio Perrino
City
Brindisi
Country
Italy
Facility Name
Ospedale A. Cardarelli
City
Campobasso
Country
Italy
Facility Name
Ospedale Ramazzini di Carpi
City
Carpi
Country
Italy
Facility Name
Ospedale S. Spirito
City
Casale Monferrato
Country
Italy
Facility Name
A.O. Garibaldi Nesima
City
Catania
Country
Italy
Facility Name
Ospedale Mater Domini
City
Catanzaro
Country
Italy
Facility Name
Ospedale della Madonna della Navicella
City
Chioggia
Country
Italy
Facility Name
Ospedale Civile di Faenza
City
Faenza
Country
Italy
Facility Name
A.O.U. Arcispedale Sant'Anna di Ferrara
City
Ferrara
Country
Italy
Facility Name
Ospedale Don Luigi Di Liegro
City
Gaeta
Country
Italy
Facility Name
IRCCS San Martino -IST Genova
City
Genova
Country
Italy
Facility Name
Ospedale F. Veneziale
City
Isernia
Country
Italy
Facility Name
A.O. Vito Fazzi-Lorusso
City
Lecce
Country
Italy
Facility Name
Ospedale Civile di Legnano
City
Legnano
Country
Italy
Facility Name
Istituto Sceintifico Romagnolo
City
Meldola
Country
Italy
Facility Name
Ospedale L. Sacco Polo Universitario
City
Milano
Country
Italy
Facility Name
Ospedale San Paolo
City
Milano
Country
Italy
Facility Name
U.L.S.S. 13
City
Mirano
Country
Italy
Facility Name
Ospedale San Gerardo
City
Monza
Country
Italy
Facility Name
Azienda Ospedaliera Cardarelli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Second University of Naples
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
A.O. Università Federico II
City
Napoli
Country
Italy
Facility Name
AORN Ospedale dei Colli - Osp Monaldi
City
Napoli
Country
Italy
Facility Name
Istituto Nazionale dei Tumori
City
Napoli
Country
Italy
Facility Name
Istituto Oncologico Veneto
City
Padova
Country
Italy
Facility Name
Ospedale Andrea Tortora Pagani - Ospedale Civile Umbero I
City
Pagani
Country
Italy
Facility Name
Casa di Cura La Maddalena
City
Palermo
Country
Italy
Facility Name
Ospedale Buccheri La Ferla - Fatebenefratelli
City
Palermo
Country
Italy
Facility Name
Fondazione Salvatore Maugeri
City
Pavia
Country
Italy
Facility Name
Ospedale Guglielmo d Saliceto-Piacenza
City
Piacenza
Country
Italy
Facility Name
Azienda Ospedaliera S. Carlo
City
Potenza
Country
Italy
Facility Name
Ospedale S. Maria delle Croci
City
Ravenna
Country
Italy
Facility Name
Ospedale Umberto I
City
Ravenna
Country
Italy
Facility Name
A.O. S. Camillo Forlanini
City
Roma
Country
Italy
Facility Name
Campus Biomedico Policlinio Universitario
City
Roma
Country
Italy
Facility Name
Ospedale S. Giovanni Calibita Fatebenefratelli
City
Roma
Country
Italy
Facility Name
Ospedale S. Andrea
City
Vercelli
Country
Italy
Facility Name
Ospedale S. Bortolo ULSS 6
City
Vicenza
Country
Italy
Facility Name
ASL Viterbo - Ospedale Belcolle
City
Viterbo
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs