Neoadjuvant Concurrent Chemoradiation With Weekly Docetaxel/Cisplatin for Resectable IIIA-N2 NSCLC
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
docetaxel/cisplatin
Radiation
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18 years older.
- Present with histologically proven or cytological diagnosis of NSCLC Stage IIIA as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer, that is amenable to surgery.
- No prior systemic chemotherapy or targeted therapy for lung cancer before screening.
- ECOG performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- Adequate hematological function:Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
- Adequate renal function:Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.
- Female subjects should not be pregnant or breast-feeding.
Exclusion Criteria:
- Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).
- History of another malignancy in the last 5 years with the exception of the following:Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted; Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Known hypersensitivity to Tarceva or gemcitabine or cisplatin.
- Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
- Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
Sites / Locations
- Peking university people's hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
chemoradiation
Arm Description
Outcomes
Primary Outcome Measures
downstage rate of mediastinal lymph nodes
Secondary Outcome Measures
overall survival
Disease-free survival
resection rate
Full Information
NCT ID
NCT01771289
First Posted
January 16, 2013
Last Updated
September 25, 2016
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01771289
Brief Title
Neoadjuvant Concurrent Chemoradiation With Weekly Docetaxel/Cisplatin for Resectable IIIA-N2 NSCLC
Official Title
Phase II Trial of Neoadjuvant Concurrent Chemoradiation With Weekly Docetaxel/Cisplatin for Resectable IIIA-N2 NSCLC
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to evaluate the safety and efficacy of neoadjuvant concurrent chemoradiation with weekly docetaxel/cisplatin in patients with resectable IIIA-N2 NSCLC.
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
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chemoradiation
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
docetaxel/cisplatin
Intervention Description
weekly docetaxel/cisplatin combined with radiation
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
chemoradiation
Primary Outcome Measure Information:
Title
downstage rate of mediastinal lymph nodes
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
5y
Title
Disease-free survival
Time Frame
5y
Title
resection rate
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18 years older.
Present with histologically proven or cytological diagnosis of NSCLC Stage IIIA as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer, that is amenable to surgery.
No prior systemic chemotherapy or targeted therapy for lung cancer before screening.
ECOG performance status of 0 or 1.
Life expectancy ≥12 weeks.
Adequate hematological function:Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
Adequate renal function:Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.
Female subjects should not be pregnant or breast-feeding.
Exclusion Criteria:
Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).
History of another malignancy in the last 5 years with the exception of the following:Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted; Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
Known hypersensitivity to Tarceva or gemcitabine or cisplatin.
Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Wang, MD
Phone
+8688324078
Email
Jwangmd@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fan Yang, MD
Phone
+8688326657
Email
dr.yangf@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Wang, MD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking university people's hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fan Yang
Phone
+8688326657
Email
dr.yangf@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Concurrent Chemoradiation With Weekly Docetaxel/Cisplatin for Resectable IIIA-N2 NSCLC
We'll reach out to this number within 24 hrs