NCT01391260

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jul 2011

Longer than P75 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 2, 2011

Status Verified

August 1, 2011

Enrollment Period

1 year

First QC Date

July 7, 2011

Last Update Submit

August 1, 2011

Conditions

Non-small Cell Lung Cancer

Keywords

Locally Advanced NSCLCEGFR Mutation PositiveRadiotherapy combined Gefitinib

Outcome Measures

Primary Outcomes (1)

  • Response rate (RR)

    1 year

Secondary Outcomes (3)

  • Progression free survival (PFS)

    2 years

  • Overall survival (OS)

    2 years

  • Quality of life (MD-Anderson questionnaire)

    1 year

Study Arms (1)

Radiotherapy Combined With Gefitinib

EXPERIMENTAL
Other: Gefitinib

Interventions

GefitinibOTHER

Radiation Therapy: 3D-CRT/IMRT 95%PTV 60-66Gy, 1.8-2.0Gy/f,5f/w; Gefitinib: 250 mg, Qd, p.o;

Also known as: Iressa
Radiotherapy Combined With Gefitinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

307 Hosptial of PLA

Beijing, Beijing Municipality, 100000, China

RECRUITING

Chinese Academy of Medical Sciences Cancer Hospital

Beijing, Beijing Municipality, 266000, China

RECRUITING

Renmin Hospital of Wuhan University, Hubei General Hospital

Wuhan, Hubei, 430060, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

Beijing Cancer Hospital

Beijing, 100000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Zhu Guangying

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Rong

CONTACT

yurong311@yahoo.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 7, 2011

First Posted

July 11, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2017

Last Updated

August 2, 2011

Record last verified: 2011-08

Locations

CN(6)