Radiotherapy Combined With Iressa for EGFR Mutation Positive Patients With Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01391260
• Other study ID #: CS-S10-09
• Status: Recruiting
• Phase: Phase 2
• First received: July 7, 2011
• Last updated: August 1, 2011
• Start date: July 2011
• Est. completion date: July 2017

Study information

• Verified date: August 2011
• Source: ZhuGuangYing
• Contact: Yu Rong
• Email: yurong311[@]yahoo.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Worldwide more than half a million new cases of lung cancer are diagnosed annually. About 80% of these tumours are of non-small cell histological type. Surgery is the treatment of choice, but only about 20% of tumours are suitable for potentially curative resection. Concurrent chemoradiotherapy is the standard treatment for locally advanced NSCLC. When Iressa was used in the first-line treatment of advanced NSCLC with EGFR mutations positive, the 12-month rates of progression-free survival were 24.9%. Therefore, we speculate that the EGFR mutations in patients with locally advanced NSCLC, Gefitinib combined with radiotherapy may be better than chemoradiotherapy. We design the study 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2017
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed diagnosis of non-squamous NSCLC; Stage ?A-?B(not suitable for surgery) or stage ?(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.

• ECOG performance Status 0-2 ;

• Patients must have a life expectancy > 12 weeks;

• Patients with laboratory values as follows:WBC>4.0 x 109/L; ANC=1.5 x 109/L; PLT=100 x 109/L; HGB=10 g/dL; CR=1.5 x ULN; TBIL<1.5 x ULN; AST and ALT=1.5 x ULN; LDH=1.5 x ULN; AKP=5 x ULN;

• FEV 1=1.0L and >50% Corresponding normal values;

• Patient candidate to standard platinum-based chemotherapy;

• Patients must be nonpregnant and non-lactating.Patients of childbearing potential must implement an effective method of contraception during the study. All female Patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.

Exclusion Criteria:

• Any evidence of clinically active interstitial lung disease;

• Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uterine and squamous cell carcinoma of the skin;

• Pregnancy or lactating;

• Serious concomitant infection;

• MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia;

• As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease);

• Patients who are not suitable to participate in the trial according to researchers.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	307 Hosptial of PLA	Beijing	Beijing
China	Beijing Cancer Hospital	Beijing
China	Chinese Academy of Medical Sciences Cancer Hospital	Beijing	Beijing
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Renmin Hospital of Wuhan University, Hubei General Hospital	Wuhan	Hubei

Sponsors (8)

Lead Sponsor	Collaborator
ZhuGuangYing	307 Hospital of PLA, Beijing Cancer Hospital, Beijing Clinical Service Center, Chinese Academy of Medical Sciences, Fudan University, Renmin Hospital of Wuhan University, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (RR)		1 year	No
Secondary	Progression free survival (PFS)		2 years	No
Secondary	Overall survival (OS)		2 years	No
Secondary	Quality of life (MD-Anderson questionnaire)		1 year	No