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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01771289
Recruitment Status : Recruiting
First Posted : January 18, 2013
Last Update Posted : September 27, 2016
Information provided by (Responsible Party):
Jun Wang, Peking University People's Hospital

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: docetaxel/cisplatin Radiation: Radiation Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Neoadjuvant Concurrent Chemoradiation With Weekly Docetaxel/Cisplatin for Resectable IIIA-N2 NSCLC
Study Start Date : January 2013
Estimated Primary Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: chemoradiation Drug: docetaxel/cisplatin
weekly docetaxel/cisplatin combined with radiation
Radiation: Radiation

Primary Outcome Measures :
  1. downstage rate of mediastinal lymph nodes [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5y ]
  2. Disease-free survival [ Time Frame: 5y ]
  3. resection rate [ Time Frame: 12 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01771289

Contact: Jun Wang, MD +8688324078
Contact: Fan Yang, MD +8688326657

China, Beijing
Peking university people's hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Fan Yang    +8688326657   
Sponsors and Collaborators
Peking University People's Hospital
Principal Investigator: Jun Wang, MD Peking University People's Hospital

Responsible Party: Jun Wang, Principal Investigator, Peking University People's Hospital Identifier: NCT01771289     History of Changes
Other Study ID Numbers: PKUPH-XW1301
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016

Keywords provided by Jun Wang, Peking University People's Hospital:
Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action