Clinical trial NCT01091376: Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC)
Official title: A Phase II Study of Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small cell lung cancer
EGFR-TKI
Erlotinib
Radiotherapy
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still controversial.The objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation treatment.

Detailed description: Patients with non-resectable Non-small Cell Lung Cancer will receive thoracic radiation therapy 60-70 Gy over 30-35 fractions and concurrent with Erlotinib 150mg/day. Followed by Erlotinib 150 mg/day consolidation treatment.

Eligibility criteria: Inclusion Criteria:

* Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc)
* Tumor EGFR mutation
* Presence of measurable disease by RECIST
* stage IIIA or IIIB, non-resectable
* ECOG performance status 0-2
* No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
* Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.

Exclusion Criteria:

* Carcinoid tumor, small cell carcinoma of lung
* Patients with any distant metastasis
* History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
* Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
* Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women
* Women and men of childbearing potential who have no willing of employing adequate contraception
* Tumor EGFR wild

Primary outcomes:
measure: Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.)
timeFrame: After the thoracic radiotherapy and concurrent Erlotinib treatment
measure: The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)
timeFrame: Every one month
Secondary outcomes:
measure: Progression free survival
timeFrame: The time from the start of treatment to diease progression
measure: The overall survival
timeFrame: The time from the start of treatment to death
measure: Quality of Life (QoL was evaluated according to the FACT-L.)
timeFrame: Every one month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Shenglin Ma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Lvhua Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: