Clinical trial NCT01391260: Radiotherapy Combined With Iressa for EGFR Mutation Positive Patients With Locally Advanced Non-small Cell Lung Cancer (NSCLC)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Locally Advanced NSCLC
EGFR Mutation Positive
Radiotherapy combined Gefitinib
Lead sponsor: ZhuGuangYing
Sponsor class: INDUSTRY
Collaborators: name: Peking University Cancer Hospital & Institute
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Zhejiang Cancer Hospital
name: Fudan University
name: Renmin Hospital of Wuhan University
name: 307 Hospital of PLA
name: Beijing Clinical Service Center
First posted: 2011-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.
* 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.

Primary outcomes:
measure: Response rate (RR)
timeFrame: 1 year
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 2 years
measure: Quality of life (MD-Anderson questionnaire)
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: 307 Hosptial of PLA
state: Beijing
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences Cancer Hospital
state: Beijing
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University, Hubei General Hospital
state: Hubei
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Zhu Guangying
role: PRINCIPAL_INVESTIGATOR
References: