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

Phase 3

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer Stage IIIB; Non-small Cell Lung Cancer Metastatic
• Interventions: Drug: Gemcitabine; Drug: Cisplatin

• Registration Number: NCT01405586
• Lead Sponsor: National Cancer Institute, Naples

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-26
• Study Start: 2011-03
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 299

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gemcitabine	Gemcitabine	-
gemcitabine + cisplatin	Cisplatin	-
gemcitabine + cisplatin	Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
overall survival	one year

Secondary Outcome Measures

Name	Time	Method
progression free survival	every 9 weeks
quality of life	baseline and 8, 21, 29, and 42 days after therapy initiated
objective response	after 9 and 18 weeks of therapy
worst grade toxicity per patient	at end of each 3 week cycle of chemotherapy	worst toxicity per patient according to Common Toxicitity Criteria for Adverse Events v. 4.03

Trial Locations

Locations (49)

Ospedale Villa Scassi; 🇮🇹 Genova, GE, Italy

Policlinico Giaccone; 🇮🇹 Palermo, PA, Italy

Azienda Ospedaliera Universitaria Senese; 🇮🇹 Siena, SI, Italy

Ospedale Regina Apostolorum; 🇮🇹 Albano Laziale, Italy

Ospedale San Lazzaro; 🇮🇹 Alba, Italy

AOU Ospedale Riuniti Umberto I; 🇮🇹 Ancona, Italy

ASL Latina Distretto 1 Aprilia Univ.degli Studi di Roma; 🇮🇹 Aprilia, Italy

Ospedale Cardinale Massaia; 🇮🇹 Asti, Italy

S. Giuseppe Moscati; 🇮🇹 Avellino, Italy

Centro Riferimento Oncologico; 🇮🇹 Aviano, Italy

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