Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by ZhuGuangYing
Sponsor:
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
Information provided by:
ZhuGuangYing
ClinicalTrials.gov Identifier:
NCT01391260
First received: July 7, 2011
Last updated: August 1, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
Other: Gefitinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ZhuGuangYing:

Primary Outcome Measures:
  • Response rate (RR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality of life (MD-Anderson questionnaire) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391260

Contacts
Contact: Yu Rong yurong311@yahoo.cn

Locations
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         
China
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
ZhuGuangYing
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
Investigators
Principal Investigator: Zhu Guangying Beijing Cancer Hospital
  More Information

No publications provided

Responsible Party: Zhu Guangying, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT01391260     History of Changes
Other Study ID Numbers: CS-S10-09
Study First Received: July 7, 2011
Last Updated: August 1, 2011
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 20, 2014