The EPIC Trial The Elderly Patient Individualized Chemotherapy Trial
EPIC
Randomized Phase III Multicenter Trial of Customized Chemotherapy Versus Standard of Care for1st Line Treatment of Elderly Patients With Advanced Non-Small-Cell Lung Cancer
1 other identifier
interventional
567
1 country
28
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2012
Longer than P75 for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 17, 2014
CompletedFirst Posted
Study publicly available on registry
January 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedNovember 4, 2020
November 1, 2020
8.4 years
November 17, 2014
November 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
primary endpoint is OS (determined from the date of randomization).Assuming an exponential survival distribution for both treatment arms and a median survival time of 8 months in the control arm we anticipate to detect an improvement of three months in OS.
from the date of randomization
Secondary Outcomes (1)
Progression Free survival
at six months determined from the date of randomization
Other Outcomes (2)
AE and SAE (according to CTCAE version 4.0)
every week from the day 1 treatment until the end of treatment (up to 18 weeks)
Rate of successfully conducted gene expression analysis in patients that have signed the informed consent document
up to10 business days of submission of the tumor specimen
Study Arms (2)
control arm
ACTIVE COMPARATORAt 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 arm
EXPERIMENTALTreatment 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.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed NSCLC.
- Stage IV NSCLC by the AJCC Staging Manual 7th edition (2010).
- Measurable or evaluable disease by RECIST 1.1.
- Age equal or more than 70 years.
- Performance Status 0 or 1 (by ECOG criteria).
- Adequate bone marrow function.
- Signed informed consent document (ICD).
- Men with partners in the childbearing age group must use effective contraception.
- Previous surgery for NSCLC (more than 30 days before study registration) is allowed.
- Previous radiotherapy is allowed if: the time between completion of RT and initiation of study treatment is at least 7 days,the patient has fully recovered from all toxic effects, and at least one target lesion or evaluable disease is outside the radiation field.
- Previous chemotherapy is allowed if the last dose was administered equal to or greater than 12 months ago. This chemotherapy must have been given in an adjuvant or neoadjuvant mode prior to or after a curative intent surgical resection for a NSCLC. Patient should be previously untreated for metastatic disease.
- Patients with stable brain metastases will be allowed to enroll. Stable brain metastasis is defined as no progression of brain metastases 14 days after conclusion of definitive treatment as documented by a CT scan or MRI of the brain.
You may not qualify if:
- Prior systemic chemotherapy or immunotherapy for advanced NSCLC.
- Prior malignancies, except: cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, or any other curatively treated malignancy with no evidence of disease recurrence for at least 2 years.
- Presence of uncontrolled brain or leptomeningeal metastases.
- Peripheral neuropathy or hearing loss of neural origin equal to or greater than grade 2 by CTCAE v 4.0 except if due to trauma.
- Other serious illness or medical condition, including but not limited to: congestive heart failure;myocardial infarction within 6 months;significant neurologic or psychiatric disorders that would impact study participation as judged by the treating physician; infection requiring I.V. antibiotics; tuberculosis with ongoing therapy at study entry, superior vena cava syndrome, except if controlled with radiation, active peptic ulcer disease; unstable diabetes mellitus;any contraindication to high dose corticosteroid therapy such as herpes simplex, herpes zoster, hepatitis, or other disease.
- Hypercalcemia requiring therapeutic intervention.
- Clinically significant ascites and/or pericardial effusion.
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
- Concurrent treatment with other investigational drugs.
- Patients known to harbor sensitizing EGFR mutations in exons 18, 19 and 21. Patients with resistance mutation in exon 20 will be allowed to enroll i.e. T790M and D770. The rare patient who has both a resistance mutation and a sensitizing mutation at the diagnoses will be excluded in the protocol.
- Patients whose tissue submission is not of adequate size to perform molecular testing will be excluded.
- Patients known to have translocations of ALK will also be excluded; however, testing for ALK translocation prior to study entry is not mandated.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
IRCSSIstituto Scientifico Romagnolo per lo studio e la cura dei tumori IRST
Meldola, Forlì, Italy
Istituto Nazionale Tumori
Aviano, Pordenone, Italy
Ospedale di Faenza
Faenza, Ravenna, Italy
Ospedale di Lugo
Lugo, Ravenna, Italy
AUSL Rimini-Oncologia Medica Cattolica
Cattolica, Rimini, Italy
AOU San Luigi Gonzaga, Department of Oncology, University of Turin
Orbassano, Turin, 10043, Italy
Ospedale Giovanni Paolo II
Bari, Italy
AO Cannizzaro
Catania, Italy
AOU Santa Croce e Carle
Cuneo, Italy
Azienda Ospedaliera Careggi
Florence, Italy
Istituto Nazionale per la Ricerca sul Cancro
Genova, Italy
Ospedale Galliera
Genova, Italy
Azienda Ospedaliera Fatebenefratelli
Milan, Italy
Ospedale S. Raffaele
Milan, Italy
AO San Gerardo
Monza, Italy
Istituto Oncologico Veneto
Padua, Italy
Ospedale Santa MAria della Misericordia
Perugia, Italy
Ospedale S MAria delle Croci
Ravenna, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
AUSL Rimini-Oncologia medica
Rimini, Italy
Istituto Nazionale Tumori Regina Elena
Roma, Italy
Ospedale S. Giovanni Addolorata
Roma, Italy
Policlinico Umberto I- Università la Sapienza
Roma, Italy
AOU Sassari
Sassari, Italy
Azienda Ospedaliera Sondalo
Sondalo, Italy
Ospedale Santa Chiara
Trento, Italy
AOU S.M. Misericordia
Udine, Italy
AOU Verona
Verona, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Silvia Novello, MD, PhD
University of Turin, Italy
- PRINCIPAL INVESTIGATOR
Giorgio Vittorio Scagliotti, MD, PhD
Univerisity of Turin
- PRINCIPAL INVESTIGATOR
Tiziana Vavalà, MD
University of Turin, Italy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 17, 2014
First Posted
January 17, 2018
Study Start
July 1, 2012
Primary Completion
December 1, 2020
Study Completion
May 1, 2021
Last Updated
November 4, 2020
Record last verified: 2020-11