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

NCT01405586 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 299

Last updated 2023-03-24

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Cesare Gridelli, M.D. · S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology

  • Francesco Perrone, M.D., Ph.D · National Cancer Institute Naples, Italy; Director Clinical Trials Unit

  • Ciro Gallo, M.D., Ph.D · Second University of Naples, Italy; Chair of Medical Statistics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01405586 on ClinicalTrials.gov