Non-small Cell Lung Cancer MetastaticPhase 3MILES-3NCT01405586
MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer
A Phase 3 study testing Gemcitabine and Cisplatin in people with Non-small Cell Lung Cancer Metastatic and Non-small Cell Lung Cancer Stage IIIB, run by National Cancer Institute, Naples at 49 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage IIIB
- What is being tested?
- Gemcitabine and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 49 sitesItaly
- Study dates
- Mar 2011to Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
Italy49 sites
Ospedale San Lazzaro
Alba
Ospedale Regina Apostolorum
Albano Laziale
AOU Ospedale Riuniti Umberto I
Ancona
ASL Latina Distretto 1 Aprilia Univ.degli Studi di Roma
Aprilia
Ospedale Cardinale Massaia
Asti
S. Giuseppe Moscati
Avellino
Centro Riferimento Oncologico
Aviano
Ospedale Senatore Antonio Perrino
Brindisi
Ospedale A. Cardarelli
Campobasso
Ospedale Ramazzini di Carpi
Carpi
Ospedale S. Spirito
Casale Monferrato
A.O. Garibaldi Nesima
Catania
Ospedale Mater Domini
Catanzaro
Ospedale della Madonna della Navicella
Chioggia
Ospedale Civile di Faenza
Faenza
A.O.U. Arcispedale Sant'Anna di Ferrara
Ferrara
Ospedale Don Luigi Di Liegro
Gaeta
Ospedale Villa Scassi
Genova, GE, 16100
IRCCS San Martino -IST Genova
Genova
Ospedale F. Veneziale
Isernia
A.O. Vito Fazzi-Lorusso
Lecce
Ospedale Civile di Legnano
Legnano
Istituto Sceintifico Romagnolo
Meldola
Ospedale L. Sacco Polo Universitario
Milan
Ospedale San Paolo
Milan
U.L.S.S. 13
Mirano
Ospedale San Gerardo
Monza
Azienda Ospedaliera Cardarelli
Naples, 80131
Second University of Naples
Naples, 80131
A.O. Università Federico II
Naples
AORN Ospedale dei Colli - Osp Monaldi
Naples
Istituto Nazionale dei Tumori
Naples
Istituto Oncologico Veneto
Padova
Ospedale Andrea Tortora Pagani - Ospedale Civile Umbero I
Pagani
Policlinico Giaccone
Palermo, PA, 90127
Casa di Cura La Maddalena
Palermo
Ospedale Buccheri La Ferla - Fatebenefratelli
Palermo
Fondazione Salvatore Maugeri
Pavia
Ospedale Guglielmo d Saliceto-Piacenza
Piacenza
Azienda Ospedaliera S. Carlo
Potenza
Ospedale S. Maria delle Croci
Ravenna
Ospedale Umberto I
Ravenna
A.O. S. Camillo Forlanini
Roma
Campus Biomedico Policlinio Universitario
Roma
Ospedale S. Giovanni Calibita Fatebenefratelli
Roma
Azienda Ospedaliera Universitaria Senese
Siena, SI, 53100
Ospedale S. Andrea
Vercelli
Ospedale S. Bortolo ULSS 6
Vicenza
ASL Viterbo - Ospedale Belcolle
Viterbo
About this study
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.
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.
- Being tested
- Gemcitabine, Cisplatin
- Keywords
- elderly, chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
1000mg/m2 days 1 and 8 every 3 weeks for 6 cycles
GemcitabineDrug
1200 mg/m2 days 1 and 8 every 3 weeks for 6 cycles
CisplatinDrug
60 mg/m2 day 1 every 3 weeks for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| gemcitabine | Active comparator | Not described Receives: Drug: Gemcitabine |
| gemcitabine + cisplatin | Experimental | Not described Receives: Drug: Gemcitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: one year
Secondary outcomes (4)
worst grade toxicity per patient
worst toxicity per patient according to Common Toxicitity Criteria for Adverse Events v. 4.03
Measured: at end of each 3 week cycle of chemotherapy
progression free survival
Measured: every 9 weeks
quality of life
Measured: baseline and 8, 21, 29, and 42 days after therapy initiated
objective response
Measured: after 9 and 18 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer MetastaticStudies 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
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cesare Gridelli, M.D., Principal investigator, S.G. Moscati Hopital, Avellino, Italy, Division of Medical OncologyFrancesco Perrone, M.D., Ph.D, Principal investigator, National Cancer Institute Naples, Italy; Director Clinical Trials UnitCiro Gallo, M.D., Ph.D, Principal investigator, Second University of Naples, Italy; Chair of Medical Statistics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405586
- Sponsor's protocol ID
- MILES-3
- Other IDs
- 2009-013540-36, 2009
- Acronym
- MILES-3
- Status last verified
- Mar 2023
- First submitted
- 26 Feb 2010
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01405586
- Acronym / sponsor ID
- MILES-3 / MILES-3
- Keywords
- elderly, chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 299 participants (actual)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 29 Jul 2011 (estimated)
- 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gemcitabine | Active comparator | Drug: Gemcitabine |
| gemcitabine + cisplatin | Experimental | Drug: Gemcitabine, Drug: Cisplatin |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Gemcitabine1000mg/m2 days 1 and 8 every 3 weeks for 6 cycles | Drug | gemcitabine + cisplatin |
| Gemcitabine1200 mg/m2 days 1 and 8 every 3 weeks for 6 cycles | Drug | gemcitabine |
| Cisplatin60 mg/m2 day 1 every 3 weeks for 6 cycles | Drug | gemcitabine + cisplatin |
Primary outcome
overall survival
Time frame: one year
4 secondary outcomes
worst grade toxicity per patient
Time frame: at end of each 3 week cycle of chemotherapy
progression free survival
Time frame: every 9 weeks
quality of life
Time frame: baseline and 8, 21, 29, and 42 days after therapy initiated
objective response
Time frame: after 9 and 18 weeks of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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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. This study is not recruiting at the moment.
Cesare Gridelli, M.D. principal investigator
S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology
Francesco Perrone, M.D., Ph.D principal investigator
National Cancer Institute Naples, Italy; Director Clinical Trials Unit
Ciro Gallo, M.D., Ph.D principal investigator
Second University of Naples, Italy; Chair of Medical Statistics
49 sites 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 Non-small Cell Lung Cancer Metastatic and Non-small Cell Lung Cancer Stage IIIB, run by National Cancer Institute, Naples at 49 sites in Italy.
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 12 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: one 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 24 Mar 2023.