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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Peking University People's Hospital
Sponsor:
Information provided by (Responsible Party):
Jun Wang, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT01771289
First received: January 16, 2013
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
Drug: docetaxel/cisplatin
Radiation: Radiation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Neoadjuvant Concurrent Chemoradiation With Weekly Docetaxel/Cisplatin for Resectable IIIA-N2 NSCLC

Resource links provided by NLM:


Further study details as provided by Peking University People's Hospital:

Primary Outcome Measures:
  • downstage rate of mediastinal lymph nodes [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 5y ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: 5y ] [ Designated as safety issue: No ]
  • resection rate [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chemoradiation Drug: docetaxel/cisplatin
weekly docetaxel/cisplatin combined with radiation
Radiation: Radiation
chemoradiation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771289

Contacts
Contact: Jun Wang, MD +8688324078 Jwangmd@yahoo.com
Contact: Fan Yang, MD +8688326657 dr.yangf@gmail.com

Locations
China, Beijing
Peking university people's hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Fan Yang    +8688326657    dr.yangf@gmail.com   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
Principal Investigator: Jun Wang, MD Peking University People's Hospital
  More Information

No publications provided

Responsible Party: Jun Wang, Principal Investigator, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01771289     History of Changes
Other Study ID Numbers: PKUPH-XW1301
Study First Received: January 16, 2013
Last Updated: January 25, 2013
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014