Neoadjuvant Concurrent Chemoradiation With Weekly Docetaxel/Cisplatin for Resectable IIIA-N2 NSCLC

Non-small Cell Lung Cancer Clinical Trial

Official title:

Phase II Trial of Neoadjuvant Concurrent Chemoradiation With Weekly Docetaxel/Cisplatin for Resectable IIIA-N2 NSCLC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01771289
• Other study ID #: PKUPH-XW1301
• Status: Recruiting
• Phase: Phase 2
• First received: January 16, 2013
• Last updated: September 25, 2016
• Start date: January 2013

Study information

• Verified date: September 2016
• Source: Peking University People's Hospital
• Contact: Jun Wang, MD
• Phone: +8688324078
• Email: Jwangmd[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• docetaxel/cisplatin
weekly docetaxel/cisplatin combined with radiation

Radiation:
• Radiation
chemoradiation

Locations

Country	Name	City	State
China	Peking university people's hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	downstage rate of mediastinal lymph nodes		8 weeks	No
Secondary	overall survival		5y	No
Secondary	Disease-free survival		5y	No
Secondary	resection rate		12 weeks	Yes