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

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ClinicalTrials.gov Identifier: NCT01391260
Recruitment Status : Unknown
Verified August 2011 by ZhuGuangYing.
Recruitment status was:  Recruiting
First Posted : July 11, 2011
Last Update Posted : August 2, 2011
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Other: Gefitinib Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Radiotherapy Combined With Gefitinib Other: Gefitinib
Radiation Therapy: 3D-CRT/IMRT 95%PTV 60-66Gy, 1.8-2.0Gy/f,5f/w; Gefitinib: 250 mg, Qd, p.o;
Other Name: Iressa

Outcome Measures

Primary Outcome Measures :
  1. Response rate (RR) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 2 years ]
  2. Overall survival (OS) [ Time Frame: 2 years ]
  3. Quality of life (MD-Anderson questionnaire) [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391260

Contact: Yu Rong yurong311@yahoo.cn

China, Beijing
307 Hosptial of PLA Recruiting
Beijing, Beijing, China, 100000
Principal Investigator: Ge Shen         
Chinese Academy of Medical Sciences Cancer Hospital Recruiting
Beijing, Beijing, China, 266000
Principal Investigator: Lvhua Wang         
China, Hubei
Renmin Hospital of Wuhan University, Hubei General Hospital Recruiting
Wuhan, Hubei, China, 430060
Principal Investigator: Qibin Song         
China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200000
Principal Investigator: Min Fan         
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310000
Principal Investigator: Shenglin Ma         
Beijing Cancer Hospital Recruiting
Beijing, China, 100000
Contact: Guangying Zhu       zgypu@yahoo.com.cn   
Contact: Rong Yu       yurong311@yahoo.cn   
Principal Investigator: Guangying Zhu         
Sponsors and Collaborators
Beijing Cancer Hospital
Chinese Academy of Medical Sciences
Zhejiang Cancer Hospital
Fudan University
Renmin Hospital of Wuhan University
307 Hospital of PLA
Beijing Clinical Service Center
Principal Investigator: Zhu Guangying Beijing Cancer Hospital
More Information

Responsible Party: Zhu Guangying, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT01391260     History of Changes
Other Study ID Numbers: CS-S10-09
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: August 2, 2011
Last Verified: August 2011

Keywords provided by ZhuGuangYing:
Locally Advanced NSCLC
EGFR Mutation Positive
Radiotherapy combined Gefitinib

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action