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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02919462
Other study ID # IRST162.10
Secondary ID 2015-003440-39
Status Terminated
Phase Phase 2
First received September 28, 2016
Last updated January 12, 2018
Start date March 2016
Est. completion date May 2017

Study information

Verified date January 2018
Source Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an open-label, multicentre, randomized phase II trial.

Eligible patients with Non Small Cell Lung Cancer (NSCLC) with high Thymidylate Synthase (TS) expression , will be randomly assigned with 1:1 ratio to the following treatment Arms:

A. 4 cycles of Cisplatin + Oral Vinorelbine followed by maintenance with Metronomic Oral Vinorelbine until disease progression

B. 4 cycles of Cisplatin + Pemetrexed followed by maintenance with Pemetrexed until disease progression

Treatment will be repeated every 21 days .


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Oral vinorelbine
Oral vinorelbine 60-80 mg/m2 on days 1 and 8 (first cycle 60 mg/m2) every 3 weeks, for 4 cycles
Cisplatin
Cisplatin 80 mg/m2 on day 1 every 3 weeks, for 4 cycles
Maintenance with Metronomic Oral Vinorelbine
Maintenance with Metronomic Oral Vinorelbine 50 mg three times a week on Monday, Wednesday and Friday continuously until disease progression, patient refusal or excessive toxicity (1 cycle: 3 weeks).
Pemetrexed
Pemetrexed, 500 mg/m2, day 1 every 3 weeks, for 4 cycles
Cisplatin
Cisplatin 75 mg/m2, day 1 every 3 weeks, for 4 cycles
Maintenance with Pemetrexed
Maintenance with Pemetrexed 500 mg/m2 day1 q 21 until disease progression (1 cycle: 3 weeks)

Locations

Country Name City State
Italy U.O. Oncologia Medica Faenza RA
Italy Ircc Irst Meldola FC
Italy Ospedale di Piacenza, ASL Piacenza Piacenza
Italy Claudio Dazzi Ravenna RA
Italy U.O. Oncologia Ospedale degli Infermi Rimini

Sponsors (2)

Lead Sponsor Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori Pierre Fabre Laboratories

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease Control Rate (DCR) Rate (DCR; complete response (CR) plus partial response (PR) plus stable disease (SD)). The response is assessed according to the RECIST 1.1 criteria. up to 36 months
Secondary Toxicity Toxicity assessed after each cycle using the Common Toxicity Criteria AE (version 4.03) up to 36 months
Secondary Overall survival (OS) within th 2 arms Overall Survival (OS) is defined as the observed length of life from study entry to death for any cause or the date of last contact for patients lost to follow up up to 36 months
Secondary Progression free survival (PFS) within the two arms Progression free survival (PFS) is the time from the date of randomization to the date of the first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation. up to 36 months
Secondary optimal TS H-score cutpoint to define the optimal Thymidylate Synthase expression(TS) H-score cutpoint in cytoplasm and/or nucleus . TS nuclear and cytoplasmic staining will be evaluated by using an intensity scale (0-3) and the percentage of cells in each category, resulting in semiquantitative H scores ranging from 0 to 300 will be calculated. Total TS H-scores will be calculated posthoc as the sum of nuclear and cytoplasm TS H-scores (range 0-600). up to 36 months
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