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The EPIC Trial The Elderly Patient Individualized Chemotherapy Trial

NCT03402048 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 567

Last updated 2020-11-04

No results posted yet for this study

Summary

This is a randomized phase III trial that will randomize elderly patients(70 years of age and older) who are not considered eligible for standard doublet or triplet regimens. In a 2:1 fashion, patients will be randomized to the customization arm or the standard arm, respectively. This trial will be offered to patients who are previously untreated for stage IV NSCLC.

The primary objective is to evaluate if chemotherapy selection based on histology and tumoral molecular determinants ERCC1, RRM1 and TS (arm A, the experimental arm) results in superior outcome in elderly patients with untreated, advanced NSCLC compared to standard of care treatments (arm B, the standard arm).

Conditions

  • Stage IV, NSCLC
  • Lung Neoplasms
  • Bronchial Neoplasms
  • Carcinoma, Bronchogenic
  • Lung Diseases
  • Neoplasms
  • Respiratory Tract Diseases
  • Respiratory Tract Neoplasms
  • Thoracic Neoplasms

Interventions

DRUG

Carboplatin

DRUG

Gemcitabine

DRUG

Pemetrexed

DRUG

Docetaxel

DRUG

Vinorelbine

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Silvia Novello, MD, PhD · University of Turin, Italy

  • Giorgio Vittorio Scagliotti, MD, PhD · Univerisity of Turin

  • Tiziana Vavalà, MD · University of Turin, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2020-12-31
Completion
2021-05-31

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 NCT03402048 on ClinicalTrials.gov