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Effect of All-trans Retinoic Acid With Chemotherapy Based in Paclitaxel and Cisplatin as First Line Treatment of Patients With Advanced Non-small Cell Lung Cancer

2014-08-27 03:16:40 | BioPortfolio

Summary

Purpose:

This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an acceptable toxicity profile and its association with the expression of Retinoic acid receptor beta 2 (RAR-beta2) as a response biomarker.

Patients and Methods:

Patients with stage IIIB and IV NSCLC were included to receive Paclitaxel and Cisplatin (PC). Patients were randomized to receive ATRA 20 mg/m2/day (RA/PC) or placebo (P/PC) 1 week prior to treatment until completing two cycles. RAR-beta2 expression was analyzed by Immunohistochemistry (IHC) and RT-PCR in tumor and adjacent lung tissue.

Description

Purpose:

This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an acceptable toxicity profile and its association with the expression of Retinoic acid receptor beta 2 (RAR-beta2 ) as a response biomarker.

Patients and Methods:

Patients with stage IIIB and IV NSCLC were included to receive Paclitaxel and Cisplatin (PC). Patients were randomized to receive ATRA 20 mg/m2/day (RA/PC) or placebo (P/PC) 1 week prior to treatment until completing two cycles. RAR-beta2 expression was analyzed by Immunohistochemistry (IHC) and RT-PCR in tumor and adjacent lung tissue.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Non-Small-Cell Lung Carcinoma

Intervention

ATRA, PLACEBO

Location

National Institute of Cancerología
Mexico City
Mexico
14080

Status

Completed

Source

National Institute of Cancerología

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:40-0400

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Medical and Biotech [MESH] Definitions

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