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Erlotinib Versus Gefitinib in Advanced Non Small Cell Lung Cancer With exon21 Mutation:A Randomized Trial

2014-08-27 03:17:36 | BioPortfolio

Summary

This is a randomized open-label controlled phase II trial comparing efficacy of erlotinib and gefitinib in patients with exon21 mutation advanced NSCLC as a first line treatment setting.

Description

Patients with stage IV NSCLC who have exon21 mutation will randomized to received oral erlotinib 150mg or gefitinib 250mg once daily until disease progression or unacceptable toxicity. Method of direct DNA sequencing of tumor tissue is used to analysis EGFR mutation status of exons 18-21. The response will be evaluated by RECIST criteria first month,second month and then repeat every 3 months after the beginning of the treatment weeks.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Thoracic Neoplasms

Intervention

erlotinib,gefitinib

Location

Guangdong General Hospital
, Guangzhou
Guangdong Province
China
510080

Status

Recruiting

Source

Chinese Society of Lung Cancer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:36-0400

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Medical and Biotech [MESH] Definitions

Neoplasms of the thin serous membrane that envelopes the lungs and lines the thoracic cavity. Pleural neoplasms are exceedingly rare and are usually not diagnosed until they are advanced because in the early stages they produce no symptoms.

New abnormal growth of tissue in the THORAX.

Diseases of the cervical (and first thoracic) roots, nerve trunks, cords, and peripheral nerve components of the BRACHIAL PLEXUS. Clinical manifestations include regional pain, PARESTHESIA; MUSCLE WEAKNESS, and decreased sensation (HYPESTHESIA) in the upper extremity. These disorders may be associated with trauma (including BIRTH INJURIES); THORACIC OUTLET SYNDROME; NEOPLASMS; NEURITIS; RADIOTHERAPY; and other conditions. (From Adams et al., Principles of Neurology, 6th ed, pp1351-2)

A collective term for precoordinated organ/neoplasm headings locating neoplasms by organ, as BRAIN NEOPLASMS; DUODENAL NEOPLASMS; LIVER NEOPLASMS; etc.

Surgery performed on the thoracic organs, most commonly the lungs and the heart.

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