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

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.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Other: Gefitinib

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100000
    • Recruiting
    • Beijing Cancer Hospital
    • Principal Investigator: Guangying Zhu
    • Contact: Guangying Zhu; Email: zgypu@yahoo.com.cn
    • Contact: Rong Yu; Email: yurong311@yahoo.cn
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • 307 Hosptial of PLA
      • Principal Investigator: Ge Shen
    • Beijing, Beijing, China, 266000
      • Recruiting
      • Chinese Academy of Medical Sciences Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Recruiting
      • Renmin Hospital of Wuhan University, Hubei General Hospital
      • Principal Investigator: Qibin Song
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Principal Investigator: MIN FAN
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Iressa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate (RR)	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression free survival (PFS)	2 years
Overall survival (OS)	2 years
Quality of life (MD-Anderson questionnaire)	1 year

Collaborators and Investigators

• Sponsor: ZhuGuangYing
• Collaborators: Zhejiang Cancer Hospital; 307 Hospital of PLA; Fudan University; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Peking University Cancer Hospital & Institute; Renmin Hospital of Wuhan University; Beijing Clinical Service Center
• Investigators: Principal Investigator: Zhu Guangying, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: July 7, 2011
• First Submitted That Met QC Criteria: July 8, 2011
• First Posted (Estimate): July 11, 2011

Study Record Updates

• Last Update Posted (Estimate): August 2, 2011
• Last Update Submitted That Met QC Criteria: August 1, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Locally Advanced NSCLC; EGFR Mutation Positive; Radiotherapy combined Gefitinib
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Gefitinib
• Other Study ID Numbers: CS-S10-09