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

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Gefitinib
Sponsored by
ZhuGuangYing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Locally Advanced NSCLC, EGFR Mutation Positive, Radiotherapy combined Gefitinib

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 307 Hosptial of PLARecruiting
  • Chinese Academy of Medical Sciences Cancer HospitalRecruiting
  • Renmin Hospital of Wuhan University, Hubei General HospitalRecruiting
  • Fudan University Shanghai Cancer CenterRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy Combined With Gefitinib

Arm Description

Outcomes

Primary Outcome Measures

Response rate (RR)

Secondary Outcome Measures

Progression free survival (PFS)
Overall survival (OS)
Quality of life (MD-Anderson questionnaire)

Full Information

First Posted
July 7, 2011
Last Updated
August 1, 2011
Sponsor
ZhuGuangYing
Collaborators
Peking University Cancer Hospital & Institute, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Zhejiang Cancer Hospital, Fudan University, Renmin Hospital of Wuhan University, 307 Hospital of PLA, Beijing Clinical Service Center
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1. Study Identification

Unique Protocol Identification Number
NCT01391260
Brief Title
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

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
ZhuGuangYing
Collaborators
Peking University Cancer Hospital & Institute, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Zhejiang Cancer Hospital, Fudan University, Renmin Hospital of Wuhan University, 307 Hospital of PLA, Beijing Clinical Service Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Locally Advanced NSCLC, EGFR Mutation Positive, Radiotherapy combined Gefitinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy Combined With Gefitinib
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Gefitinib
Other Intervention Name(s)
Iressa
Intervention Description
Radiation Therapy: 3D-CRT/IMRT 95%PTV 60-66Gy, 1.8-2.0Gy/f,5f/w; Gefitinib: 250 mg, Qd, p.o;
Primary Outcome Measure Information:
Title
Response rate (RR)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Time Frame
2 years
Title
Overall survival (OS)
Time Frame
2 years
Title
Quality of life (MD-Anderson questionnaire)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Rong
Email
yurong311@yahoo.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhu Guangying
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
307 Hosptial of PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ge Shen
Facility Name
Chinese Academy of Medical Sciences Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
266000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lvhua Wang
Facility Name
Renmin Hospital of Wuhan University, Hubei General Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qibin Song
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Fan
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shenglin Ma
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangying Zhu
Email
zgypu@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Rong Yu
Email
yurong311@yahoo.cn
First Name & Middle Initial & Last Name & Degree
Guangying Zhu

12. IPD Sharing Statement

Learn more about this trial

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

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