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Report for Clinical Trial NCT01391260

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Trial of Radiation Therapy Combined With Iressa in Patients With Locally Advanced Non-small Cell Lung Cancer With Harboring Active EGFR Mutations

The purpose of this study is to access the effect and safety of radiotherapy combined whth Iressa for patients with locally advanced non-small cell lung cancer with harboring active EGFR mutations.

NCT01391260 Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: Gefitinib

Description: Radiation Therapy: 3D-CRT/IMRT 95%PTV 60-66Gy, 1.8-2.0Gy/f,5f/w; Gefitinib: 250 mg, Qd, p.o;
Type: Other
Group Labels: 1

Radiotherapy Combined With Gefitinib


Primary Outcomes

Measure: Response rate (RR)

Time: 1 year

Secondary Outcomes

Measure: Progression free survival (PFS)

Time: 2 years

Measure: Overall survival (OS)

Time: 2 years

Measure: Quality of life (MD-Anderson questionnaire)

Time: 1 year

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 L858R

Inclusion Criteria: - Histologically confirmed diagnosis of non-squamous NSCLC; Stage ⅢA-ⅢB(not suitable for surgery) or stage Ⅳ(only single-site single transfer ); - Untreated patients, or who completed ≤ 2 cycles of first-line chemotherapy (chemotherapy regimen: paclitaxel, docetaxel + cisplatin) within the previous month; - Patients with tumor EGFR mutation positive (exon 19 deletion mutation or exon 21 L858R substitution mutation); - Patients must be informed of the investigational nature of the study and must sign an informed consent form; - Presence of at least one measurable/evaluable according to RECIST criteria. --- L858R ---



HPO Nodes


HPO: