NCT01771289

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

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

January 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

4 years

First QC Date

January 16, 2013

Last Update Submit

September 25, 2016

Conditions

Non-small Cell Lung Cancer

Keywords

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • downstage rate of mediastinal lymph nodes

    8 weeks

Secondary Outcomes (3)

  • overall survival

    5y

  • Disease-free survival

    5y

  • resection rate

    12 weeks

Study Arms (1)

chemoradiation

EXPERIMENTAL
Drug: docetaxel/cisplatinRadiation: Radiation

Interventions

docetaxel/cisplatinDRUG

weekly docetaxel/cisplatin combined with radiation

chemoradiation
RadiationRADIATION

chemoradiation

chemoradiation

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking university people's hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

DocetaxelCisplatinRadiation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPhysical Phenomena

Study Officials

  • Jun Wang, MD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Wang, MD

CONTACT

+8688324078Jwangmd@yahoo.com

Fan Yang, MD

CONTACT

+8688326657dr.yangf@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 18, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2017

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

CN(1)