The EPIC Trial The Elderly Patient Individualized Chemotherapy Trial
NCT ID: NCT03402048
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
567 participants
INTERVENTIONAL
2012-07-31
2021-05-31
Brief Summary
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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).
Detailed Description
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Tissue will be obtained, and gene expression analysis will be performed at the University of Turin. The tissue sample used for this analysis will be obtained from the biopsy procedure performed as standard of care procedures during the patient's diagnosis and staging. Patients will be randomized to either Arm A: Experimental or Arm B: Standard of Care in a 2:1 fashion.
Tissue will be obtained for gene analysis for ALL patients. However, ONLY patients randomized to Arm A will receive the genetic analysis results. Genetic results will not be disclosed to the registering center for those patients randomized to Arm B: Standard of Care.
For patients randomized to Arm A: Experimental arm, the chemotherapy treatment prescription will be based on the gene analysis according to the protocol. For patients randomized to Arm B: Standard of Care arm, the chemotherapy treatment will be at the discretion of the care provider.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Carboplatin
Gemcitabine
Pemetrexed
Docetaxel
Vinorelbine
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.
Carboplatin
Gemcitabine
Pemetrexed
Docetaxel
Vinorelbine
Interventions
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Carboplatin
Gemcitabine
Pemetrexed
Docetaxel
Vinorelbine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
70 Years
ALL
No
Sponsors
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University of Turin, Italy
OTHER
Responsible Party
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Prof. Silvia Novello
Principal Investigator
Principal Investigators
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Silvia Novello, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Turin, Italy
Giorgio Vittorio Scagliotti, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Univerisity of Turin
Tiziana Vavalà, MD
Role: PRINCIPAL_INVESTIGATOR
University of Turin, Italy
Locations
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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, 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
Countries
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Central Contacts
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Facility Contacts
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Marco Angelo Burgio, MD
Role: primary
Alessandra Bearz, MD
Role: primary
Alessandro Gamboni, MD
Role: primary
Gianni Michele Turolla, MD
Role: primary
Maximilian Papi, MD
Role: primary
Domenico Galetta, MD
Role: primary
Giuseppe Banna, MD
Role: primary
Ida Colantonio, MD
Role: primary
Fabiana Cecere, MD
Role: primary
Francesco Grossi, MD
Role: primary
Carlotta Defferrari, MD
Role: primary
Gabriella Farina, MD
Role: primary
Vanesa Gregorc
Role: primary
Paolo Bidoli, MD
Role: primary
Adolfo Favaretto, MD
Role: primary
Lucio Crinò, MD
Role: primary
Claudio Dazzi, MD
Role: primary
Corrado Boni, MD
Role: primary
Maximilian Papi, MD
Role: primary
Francesco Cognetti, MD
Role: primary
oLGA Martelli, MD
Role: primary
Enrico Cortesi, MD
Role: primary
Lorenzo Cordero, MD
Role: primary
Giuseppe Valmadre, MD
Role: primary
Orazio Caffo, MD
Role: primary
Alessandro Follador, MD
Role: primary
Gianpaolo Tortora, MD
Role: primary
Other Identifiers
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2012-001194-81
Identifier Type: -
Identifier Source: org_study_id