The EPIC Trial The Elderly Patient Individualized Chemotherapy Trial

Sponsor
University of Turin, Italy
Study ID
NCT03402048
Phase
PHASE3
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
  • Gemcitabine — DRUG
  • Pemetrexed — DRUG
  • Docetaxel — DRUG
  • Vinorelbine — DRUG

Study Details

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).

Key Dates

Start date
Jul 31, 2012
Status verified
Nov 2020
Primary completion
Dec 31, 2020
Completion
May 31, 2021

Study Design

Enrollment
567 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: control arm
    At discretion of the treating phisician. Common chemotherapic regimens include: Gemcitabine at 1000 or 1250 mg/m2 IV (in the vein) on day 1 and 8 of each 21 day cycle. Carboplatin at an AUC of 5 IV on day 1 of each 21 day cycle plus Gemcitabine at 1000 mg/m2 IV on Day 1 and 8 of each 21 day cycle. Carboplatin at an AUC of 5 IV on Day 1 of each 21 day cycle plus Pemetrexed 500mg/m2 on day 1 IV on Day 1 of each 21 day cycle. Vinorelbine 30 mg/m2 IV on day 1 and day 8 every 3 of each 21 day cycle. Number of Cycles: to a maximum of 6 cycles until progression or unacceptable toxicity.
  • Experimental: experimental arm
    Treatment prescriptions will be based on gene analysis: * Carboplatin at an AUC of 6 IV (in the vein) on day 1 of each 21 day cycle. * Gemcitabine at 1000 mg/m2 IV on day 1 and 8 of each 21 day cycle. * Carboplatin at an AUC of 5 IV on day 1 of each 21 day cycle plus Gemcitabine at 1000 mg/m2 IV on Day 1 of each 21 day cycle. * Carboplatin at an AUC of 5 IV on Day 1 of each 21 day cycle plus Pemetrexed at 500 mg/m2 IV on Day 1 of each 21 day cycle. * Pemetrexed 500mg/m2 IV on Day 1 of each 21 day cycle. * Docetaxel 75 mg/m2 IV on Day 1 of each 21 day cycle. Or Vinorelbine 30 mg/m2 IV on day 1 and day 8 of each 21 day cycle. Number of Cycles: to a maximum of 6 cycles until progression or unacceptable toxicity.

Primary Outcome Measure

Overall Survival [ Time Frame: from the date of randomization ]

Central Contacts

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